SUPPLY AGREEMENT
THIS
SUPPLY AGREEMENT (hereinafter
"Agreement") is made this 28th
day of
June, 2008, by and between InovaChem Inc., a Delaware corporation, with
headquarters at 0000
Xxxx
Xxx Xxxx, Xxxxx 0000, Xxxxxxx, Xxxxx 00000, XXX (hereinafter
“InovaChem”),
and
Polymed
Therapeutics Inc., a Texas corporation, with
headquarters
at 0000
Xxxx Xxx Xxxx, Xxxxx 0000, Xxxxxxx, Xxxxx 00000, XXX (hereinafter
“Polymed”).
RECITALS
|
A.
|
InovaChem
owns the Intellectual Property (as defined below), which relates
to the
manufacture of sucralose.
|
|
B.
|
Polymed
manufactures food
and pharmaceutical ingredients for use in products similar to sucralose.
|
|
C.
|
InovaChem
and Polymed desire that Polymed manufacture sucralose exclusivelyfor
InovaChem on the terms and conditions set forth in this
Agreement.
|
AGREEMENT
In
consideration of the premises, and for other good and valuable consideration,
the receipt and sufficiency of which hereby are acknowledged, the parties hereby
agree as follows:
1. Definitions. In
this
Agreement the following terms shall have the following meanings whenever such
terms are used:
(a) “Cost
Price” shall mean the cost of manufacturing the Product as set forth on
Schedule
A
attached
hereto.
(b) “Intellectual
Property” shall mean any and all patent, patent application and other patent
right, copyright, trademark, and tradename owned by or licensed to InovaChem,
its subsidiaries and affiliates, including but not limited to those set forth
on
Schedule
B
attached
hereto.
(c) “Product”
shall mean sucralose and sucralose products manufactured in accordance with
the
Intellectual Property.
(d)
“Regulations”
shall mean any and all Federal and State laws, including without limitation,
the
regulations, policies and guidelines promulgated by the U.S. Food and Drug
Administration and other applicable regulatory authorities, with respect to
the
manufacturing and testing practices for products similar to the
Product.
1
(e)
“Specifications”
shall mean the technical specifications for the manufacture of the Product
as
set forth on Schedule
C
attached
hereto.
2. Term.
This
Agreement shall be effective from the date first set forth above (the “Effective
Date”). The term of this Agreement shall be for a period of thirty-six (36)
months from the Effective Date. This Agreement shall automatically renew for
successive twelve (12) month periods, unless a party provides notice to the
other party within ninety (90) days prior to the expiration of the term of
this
Agreement, as such term may have been extended, that such party does not wish
to
extend the term of this Agreement. This Agreement may also be terminated by
either party upon ninety (90) days prior written notice to the other party.
3. Purchase
Orders; Delivery of Product.
(a) Polymed
shall manufacture the Product pursuant to the Specifications and in accordance
with the Intellectual Property, and deliver to InovaChem the Product in such
quantities as InovaChem may order from time to time pursuant to one or more
purchase orders (each a “Purchase Order”) in accordance with the terms of this
Agreement. Each Purchase Order will set forth the Product ordered, the quantity
of such Product and the Purchase Price for the Product calculated in accordance
with Schedule
A.
The
delivery date for the Product will be sixty (60) days from the date of the
Purchase Order. Polymed shall promptly notify InovaChem of any change in the
lead time. Polymed shall confirm in writing its acceptance of each Purchase
Order upon receipt of such Purchase Order. Delivery for all Products will be
F.O.B. ex-factory. InovaChem shall be responsible for all costs associated
with
transporting and importing the Product, including, without limitation, freight
fees, insurance, taxes, customs, duties, licenses, permits and other
governmental fees required to deliver the Product to the destination of
InovaChem’s choice. In
January of each year, InovaChem shall provide a forecast of the quantity of
Product InovaChem anticipates purchasing during such year. Such forecast shall
not bind InovaChem to order the forecasted amount during such year.
(b) The
parties acknowledge that the Product to be manufactured and delivered pursuant
to the Purchase Orders shall not be sold directly to consumers at this time.
If
at any time in the future, Product delivered pursuant to any Purchase Order
is
to be sold directly to consumers, InovaChem shall identify that such Product
is
for sale to consumers on the Purchase Order and provide the appropriate labeling
and packaging for such Product that complies in all respects with the
Regulations.
4.
Price:
Payment.
InovaChem shall purchase the Product from Polymed for the Cost Price plus
fifteen (15%) percent (the “Purchase Price”). Payment terms shall be net thirty
(30) days from shipment of the Product by Polymed. Payment will be made by
bank
wire transfer pursuant to the wire transfer instructions Polymed provides.
Polymed
shall invoice InovaChem for Product on a monthly basis. The invoice shall
be
calculated in accordance with Schedule A and shall be subject to Financial
Audit
(as defined below) by Inovachem in accordance with this Agreement.
2
5. Confidentiality.
(a) The
term “Confidential Information” means all products, services, systems,
technology, designs, devices, processes, plans, ideas, innovations, knowledge,
know-how, diagrams, directions, specifications, models, formulae, discoveries,
developments, modifications, data and other information relating to, owned
or
used by InovaChem or any parent, subsidiary or affiliate of InovaChem, or to
any
business in which InovaChem, or any parent, subsidiary or affiliate of InovaChem
is engaged or contemplates becoming engaged; all business plans, development
plans, site plans, architectural and engineering plans, marketing plans,
marketing strategies, existing and prospective customer lists and information
of
InovaChem or any parent, subsidiary or affiliate of InovaChem, or relating
to
any business in which InovaChem, or any parent, subsidiary or affiliate of
InovaChem is engaged or contemplates becoming engaged; all information or data
supplied by or concerning InovaChem, or any parent, subsidiary or affiliate
of
InovaChem, or any client, equity partner, lender or customer of any of the
foregoing or any business in which any such clients, equity partner, lender
or
customers are engaged or contemplate becoming engaged; and all trade secrets
and
confidential information belonging to InovaChem or any parent, subsidiary or
affiliate of InovaChem. In addition, Confidential Information shall include
all
Intellectual Property, including without limitation any and all patent, patent
application, patent right, and all improvements and enhancements thereto (as
set
forth on Schedule
B),
owned
or developed by InovaChem, or any parent, subsidiary or affiliate of InovaChem,
or any employee, contractor, consultant, agent or licensee/licensor of any
of
the foregoing. Confidential information shall not belong to or be deemed to
be
in the public domain merely as a result of such Confidential Information being
in the prior possession of Polymed.
(b)
As a
consequence of the parties’ relationship with each other, Polymed will receive
and deal with Confidential Information belonging to InovaChem. Polymed further
acknowledges that Confidential Information to be received or dealt with by
it is
of such a value and nature to InovaChem, and/or protected from disclosure by
Regulations, as to make it reasonable and necessary for the protection and
non-disclosure of the Confidential Information to any third party, and that
InovaChem will be irreparably damaged if Polymed were to disclose any of the
Confidential Information that it receives or deals with. Polymed acknowledges
and agrees that all Confidential Information regarding InovaChem or its parents,
subsidiaries or affiliates which is compiled or obtained by Polymed or furnished
to it in connection with the parties’ relationship is InovaChem’s exclusive
property, and that said Confidential Information shall not be disclosed to
any
person, firm or entity, any time during or after the term of this Agreement,
except as required to perform the transaction contemplated by this Agreement.
Polymed agrees and acknowledges that it shall have no right, title or interest
in the Confidential Information belonging to InovaChem. Polymed recognizes
that,
notwithstanding the provisions of this Agreement, InovaChem may legitimately
refuse to disclose, or may defer disclosure of, certain Confidential Information
to the extent that it is not necessary for the purpose of this Agreement. Upon
demand by InovaChem, and in any event within three (3) days following the
termination of this Agreement, Polymed will surrender to InovaChem all
Confidential Information and all other original and facsimile records, documents
and data in Polymed’s possession or control pertaining to or belonging to
InovaChem.
3
(c)
In
the event that Polymed is requested or required (by deposition, interrogatories,
requests for information or documents in legal, regulatory or administrative
proceedings, subpoenas, civil investigative demand or similar process), in
connection with any proceeding, to disclose any Confidential Information
belonging to InovaChem, Polymed will give InovaChem prompt written notice of
such request or requirement so that InovaChem may seek an appropriate protective
order or other remedy and/or waive compliance with the provisions of this
Agreement, and Polymed will cooperate with InovaChem to obtain such protective
order or remedy. In the event that such protective order or other remedy is
not
obtained or InovaChem waives compliance with the relevant provisions of this
Agreement, Polymed will furnish only that portion of the Confidential
Information which, in the opinion of its counsel, is legally required to be
disclosed and, will use its best efforts to obtain assurances that confidential
treatment will be accorded to such information.
6. Existing
Intellectual Property. Polymed
shall have no rights in and to the Intellectual Property as a result of being
a
prior assignee of such Intellectual Property. InovaChem shall retain all right,
title and interest arising under the United States Patent Act, the United States
Trademark Act, the United States Copyright Act and all other applicable
Regulations relating to the Intellectual Property, the Product, and any label,
trademark or tradename associated therewith (collectively, "InovaChem's
Intellectual Property"). Neither Polymed nor any third party shall acquire
any
right, title or interest in InovaChem's Intellectual Property by virtue of
this
Agreement or otherwise, except to the extent expressly provided
herein.
7. Individually
Owned Inventions.
Except
as the parties may otherwise agree in writing, any Invention (as defined herein)
which is conceived, reduced to practice, or created by Polymed in the course
of
performing its obligations under this Agreement as it relates to the Products
and Intellectual Property shall be solely owned by InovaChem, whether or not
InovaChem is the inventing party. Any and all use and exploitation of the
Invention shall be solely at the discretion of InovaChem. For purposes of this
Agreement, "Invention" shall mean any invention, innovation, improvement,
development, discovery, computer program, device, trade secret, method,
know-how, process, technique or the like, whether or not written or otherwise
fixed in any form or medium, regardless of the media on which contained and
whether or not patentable or copyrightable. Polymed shall assign, or cause
to be
assigned, to InovaChem
all
patent rights and other intellectual property rights covering any Invention.
8. Exclusivity.
Polymed
shall manufacture the Product exclusively for InovaChem. Polymed shall not
manufacture, sell or otherwise supply Product or any other sucralose-related
product to any third party without the prior written consent of
InovaChem.
9. Specifications:
Manufacturing process.
Polymed
shall manufacture the Product in accordance with the Specifications and the
manufacturing process of the Intellectual Property. Polymed shall not modify
or
deviate from the Specifications or the manufacturing process pursuant to the
Intellectual Property without the prior written consent of InovaChem.
Polymed
shall test, or cause to be tested, each batch of Product manufactured pursuant
to this Agreement before delivery to InovaChem to ensure the Product conforms
with the Specifications in all respects. A certificate of analysis for each
batch of Product will be delivered to InovaChem that sets forth the items tested
and such test results. Polymed shall send such certificate to InovaChem prior
to
or at the time the Product is shipped to InovaChem. Polymed will obtain and
maintain all permits and licenses required for it to carry out its obligations
pursuant to this Agreement, and will comply with all applicable Regulations
in
connection with manufacturing, handling, storage, distribution, and resale
of
any Product delivered to InovaChem. Polymed may use subcontractors
located
in the People’s Republic of China
to
fulfills its manufacturing obligations under this Agreement; provided, however,
that Polymed must obtain InovaChem’s prior written consent of any subcontractor
that Polymed seeks to use to manufacture the Product in accordance with Section
21. Polymed
shall
maintain internal standard operating procedures as to product recalls and the
treatment of product complaints and inquiries regarding safety, quality or
efficacy that are in keeping with accepted standards in the United States,
and
shall promptly notify InovaChem of any issues associated with the Product of
which Polymed becomes aware.
4
10. Warranties.
Polymed
represents and warrants to and covenants with InovaChem that upon delivery,
the
Product shall conform to the Specifications in all respects, and it shall have
been manufactured in accordance with the Intellectual Property. Polymed
covenants that the Product will be manufactured in accordance with all
applicable Regulations, including applicable United States Federal laws and
regulations, and applicable regulations of the countries where the Product
may
be sold or distributed. Polymed covenants that the Product will be fit for
consumption by humans and animals. EXCEPT
AS
EXPRESSLY SET FORTH IN THIS AGREEMENT, POLYMED MAKES NO OTHER WARRANTIES,
EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCT, INCLUDING, BUT NOT LIMITED TO,
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
11.
Audit.
(a)
InovaChem shall have the right to visit and audit Polymed’s manufacturing
facilities to determine compliance with this Agreement and the Regulations,
and
that the Product is being manufactured in accordance with the Specifications
and
the manufacturing process pursuant to the Intellectual Property. Such audits
shall be scheduled at mutually agreeable times upon not less than five (5)
days
written notice to Polymed, and shall be at InovaChem’s expense. An audit may be
made upon advance notice of less than five (5) days upon a showing of good
cause
as a result of any quality issues of which InovaChem may become
aware.
(b)
InovaChem shall have the right to conduct financial audits (hereinafter
“Financial Audit”) from time to time, in its sole discretion, and at its sole
cost (except as described below) to calculate the Cost Price. Polymed shall
provide all documents requested by InovaChem, including but not limited to,
all
receipts, invoices, and accounting records of the costs comprising the Cost
Price as set forth in Schedule
A.
If such
Financial Audit reveals that the Cost Price was overstated by more than five
percent (5%), then Polymed shall bear the cost of the Financial
Audit.
5
12. Non-Conforming
Product.
If
within ninety (90) days after accepting delivery of any Product, InovaChem
determines that all or any part of such Product was non-conforming upon the
date
of delivery, InovaChem may reject such non-conforming Product by giving written
notice to Polymed. InovaChem shall provide all analysis results with respect
to
such non-conforming Product to Polymed. Polymed shall reimburse InovaChem for
the amount of the Purchase Price and all other costs paid by InovaChem in
connection with such non-conforming Product, including without limitation all
freight and shipping charges and all testing costs. Polymed shall
use
commercially reasonable efforts to replace non-conforming Product with
conforming Product
promptly. In the event that Polymed does not agree that such Product is
non-conforming, Polymed, at it sole expense, shall have the right to submit
such
Product to a third party laboratory, mutually agreed to by the parties, for
testing. The results of the third party laboratory shall be binding upon the
parties. If Product is determined by the third party laboratory to be
conforming, InovaChem shall reimburse Polymed for the cost of testing the
Product by the third party laboratory.
13. Relationship
of Parties.
This
Agreement shall not constitute or be construed as creating a partnership or
joint venture between InovaChem and Polymed, and neither party shall be liable
for any debts or obligations of the other party. Neither party shall in any
way
be considered an agent or representative of the other party in any dealings
with
any third party, and neither party may act for, nor bind, the other party in
any
such dealings.
14. Indemnity.
(a)
Polymed shall indemnify, defend and hold harmless InovaChem, and its
subsidiaries, affiliates, successors and assigns and its and their respective
shareholders, members, managers, officers, directors, employees, stockholders,
agents and affiliates from and against any and all damages, claims, losses,
liabilities and expenses, including, without limitation, legal fees and
expenses, arising from, through or in any manner related to (i) any breach
by
Polymed of its obligations under this Agreement; (ii) any act or omission of
Polymed or its employees, agents, independent contractors, invitees, or
licensees in connection with Polymed’s performance under this Agreement, and
(iii) liability for any premiums, taxes, or contributions of or with respect
to
Polymed, and its employees, agents or independent contractors that may be
assessed against InovaChem.
(b)
InovaChem shall indemnify, defend and hold harmless Polymed and its affiliates,
successors and assigns and its and their respective shareholders, officers,
directors, employees, stockholders, agents and affiliates from against any
and
all damages, claims, losses, liabilities and expenses, including, without
limitation, legal fees and expenses, arising from, through or in any manner
related to (i) any breach by InovaChem of its obligations under this Agreement;
(ii) any
liability arising out of or resulting from any Product that
complies with the Specifications and was manufactured pursuant to the
Intellectual Property unless such liability also results from a breach by
Polymed of its obligations under this Agreement; (iii) any
liability arising out of or resulting from InovaChem’s compliance or
noncompliance with any Regulation;
and (iv)
liability for any premiums, taxes, or contributions of or with respect to
InovaChem, and its employees, agents or independent contractors that may be
assessed against Polymed.
6
15.
Limitation
of Liability.
To the
extent permitted under applicable Regulations and except for a breach of Section
5, neither party shall be liable to the other party for any special,
consequential, exemplary or incidental damages, arising from any claim relating
to this Agreement, whether such claim is based on contract, tort (including
negligence) or otherwise, even if it has been advised of the possibility or
likelihood such damages. Notwithstanding the foregoing, nothing in this section
shall limit either party’s right to indemnification for claims by third parties
seeking any special, consequential, exemplary or incidental
damages.
16. Insurance
Policies. InovaChem
shall procure all insurance policies in connection with the Product, including
without limitation a policy covering claims for product liability. Polymed
shall
be named as an additional insured on any product liability insurance policy
procured by InovaChem with respect to the Product.
17. Notices.
All
notices, requests, consents and other communications required or permitted
under
this Agreement shall be in writing and shall be deemed to have been properly
given (a) upon delivery, if delivered in person or by facsimile transmission
with receipt acknowledged by the recipient thereof, (b) one business day after
having been deposited for overnight delivery with any reputable overnight
courier service, or (c) three business days after having been deposited in
any
post office or mail depository regularly maintained by the U.S. Postal Service
and sent by registered or certified mail, postage prepaid, return receipt
requested, addressed as follows:
|
If
to InovaChem:
|
0000
Xxxx Xxx Xxxx, Xxxxx 0000,
Xxxxxxx,
Xxxxx 00000, XXX
|
|
Attention:
Xxxxx Toh
|
|
|
If
to Polymed:
|
0000
Xxxx Xxx Xxxx, Xxxxx 0000,
Xxxxxxx,
Xxxxx 00000, XXX
|
|
Attention:
Xxxxxxx X. Xxx, PhD.
|
Any
party
hereto may change the address to which communications or copies are to be sent
to such party by giving notice of such change of address in conformity with
the
provisions of this Section for the giving of notice.
18. No
Waiver.
The
failure of either party to this Agreement to insist on the performance of any
of
the terms and conditions of this Agreement, or the waiver of any breach of
any
of the terms and conditions of this Agreement, shall not be construed as a
continuing waiver or as a waiver of any other terms and conditions, but such
terms and conditions shall continue and remain in full force and effect as
if no
forbearance or waiver had occurred.
19.
Governing
Law; Jurisdiction.
This
Agreement shall be governed by and construed in accordance with the laws of
the
State of Texas without giving effect to its conflicts of laws principles. Each
party hereby irrevocably submits to the exclusive jurisdiction of the courts
of
the State of Texas and the United States District Court for the State of Texas,
for the purpose of any action or proceeding arising out of or relating to this
Agreement and each party hereby irrevocably agrees that all claims in respect
of
such action or proceeding may be heard and determined exclusively in any Texas
state or federal court. Each party agrees that a final judgment in any action
or
proceeding shall be conclusive and may be enforced in other jurisdictions by
suit on the judgment in any other matter provided by law.
7
20. Partial
Invalidity.
If any
one or more of the provisions contained in this Agreement shall, for any reason,
be held to be invalid, illegal or unenforceable in any respect, this Agreement
shall be reformed to eliminate such invalid, illegal or unenforceable provisions
and this Agreement shall be construed in an enforceable manner that best
achieves the parties’ intent in entering into this Agreement.
21. Assignment;
Binding Effect.
Neither
party may assign its rights or obligations, in whole or in part, hereunder
without the prior written consent of the other party. Polymed may not
subcontract any of its manufacturing obligations hereunder without the prior
written consent of InovaChem. Any attempt to assign this Agreement without
the
prior written consent of the other party shall be void. If InovaChem permits
Polymed to delegate certain of its obligations hereunder, at a minimum, Polymed
(a) shall remain obligated to InovaChem under this Agreement; (b) shall be
liable for the performance of its subcontractor; (c) shall indemnify InovaChem
for any claims against InovaChem, and/or its subsidiaries, affiliates,
successors and assigns, and their respective shareholders, members, managers,
officers, directors, employees, stockholders, agents and affiliates, as a result
of the acts or omissions of its subcontractor; and (d) shall assure that
InovaChem has the right to inspect the facilities of the subcontractor (similar
to the inspection rights provided hereunder), which facilities may be located
in
China. The terms of this Agreement shall be binding on and inure to the benefit
of the parties and their respective permitted successors and permitted assigns.
22.
Modification Of Agreement.
Any
modification of this Agreement shall be in writing signed by both parties
hereto.
23. Survival
Of Rights.
The
termination of this Agreement for any reason shall be without prejudice to,
and
shall not affect, the right of each party to recover from the other party any
and all damages to which such party may be entitled. In addition, any
termination of this Agreement shall not release the parties from liabilities
and
obligations accrued as of the date thereof. Notwithstanding anything to the
contrary that may be contained herein, in the event of the termination or
expiration of this Agreement, the idemnification and confidentiality obligations
contained herein shall survive such termination or expiration.
24. Force
Majeure.
The
parties shall not be liable for the failure or delay in performing any
obligation under this Agreement if and to the extent such failure or delay
is
due to causes beyond the reasonable control of the affected party, including
a)
acts of God, b) weather, fire or explosion, c) war, invasion, riot or other
civil unrest; d) changes in governmental laws, orders, restrictions, actions,
embargoes or blockages, e) national or regional emergency, f) injunctions,
strikes, lockouts, labor trouble or other industrial disturbances, g) shortage
of adequate fuel, power, materials or transportation facilities, or h) or any
other event which is beyond the reasonable control of the affected party,
provided that the party affected shall promptly notify the other as soon as
practicable, in writing, and in all events within ten (10) business days of
the
force majeure condition, and shall be required to use its best efforts to
eliminate, cure or overcome any such causes and to resume performance of its
obligations as soon as possible.
8
25. Entire
Agreement.
This
Agreement embodies the entire agreement between the parties with respect to
the
subject matter expressed herein and supersedes all prior agreements, whether
written or oral.
26. Counterparts.
This
Agreement may be executed in any number of counterparts, each of which shall
be
deemed to be an original, but all of which together shall constitute but one
and
the same instrument.
The
parties hereto have caused this Agreement to be executed on the date first
written above.
| InovaChem Inc. | Polymed Therapeutics Inc. | ||
| By: /s/ Xxxxx Toh | By: /s/ Xxxxxxx X. Xxx | ||
|
Printed:
Xxxxx
Toh
Title:
Executive Vice President
|
Printed: Xxxxxxx X. Xxx, PhD. Title: President |
9
SCHEDULE
A
CALCULATION
OF PRICE TO BE CHARGED BY POLYMED TO INOVACHEM
Definitions:
| · |
Direct
costs - labor, mechanical materials, packaging, raw materials (sugar,
solvents, chemicals - to be identified), and
transportation.
|
| · |
Indirect
costs - utilities (water, electricity, steam, waste disposal)
-
at the actual cost billed to Polymed and its affiliates with an allocation
to Product to be agreed upon by both parties based upon use of the
applicable facilities to manufacture Product versus use for other
purposes.
|
| · |
Overhead
- Equipment depreciation, insurance, property taxes, and salaries
(not
included in direct labor) with
an allocation to Product to be agreed upon by both parties based
upon the
overhead applicable to manufacture Product versus use for other
purposes.
|
Cost
Price:
The
Cost
Price shall be the sum of all costs for the manufacture of Product, which
include direct costs, indirect costs, overhead and any other costs directly
attributable to manufacture of Product.
Calculation
of the Cost Price shall be determined as follows:
| 1. |
Actual
direct costs plus
|
| 2. |
Allocation
of indirect costs using agreed upon percentages
plus
|
| 3. |
Allocation
of overhead using agreed upon
percentages
|
Purchase
Price:
Total
of
Cost Price plus fifteen (15%) percent. Should
the Purchase Price calculated in accordance with this Schedule be greater than
the global market price of the Product, both parties shall negotiate and adjust
the Purchase Price accordingly, to a mutually agreeable price to both
parties.
10
SCHEDULE
B
INTELLECTUAL
PROPERTY
| 1. |
U.S.
Patents Applications.
|
| Application No. 11/898,652 - Novel Process for preparing sucrose 6-ester |
|
Application
No. 11/806,810 - Novel Chlorination process for preparing
sucralose
|
|
Application
No. 12/003,850 - CIP of 11/806,810
|
11
SCHEDULE
C
SPECIFICATIONS
SUCRALOSE
(Product)
The
Product shall be manufactured to meet either of the following specifications,
as
stated in the certificate of analysis, and these criteria, unless otherwise
agreed to between the parties, shall be InovaChem’s criteria for determining
whether to accept Product:
Specification
I:
United
States Pharmacopeia, 30th
Revision (Assay), 29th
Revision (xxxx xxxxxx), 28th
Revision (Residue on Ignition)
Sucralose
contains not less than 98.0 percent and not more than 102.0 percent of
C12H19Cl3O8,
calculated on the anhydrous basis.
Identification—
A:
Infrared
Absorption [Missing Graphic Reference]197K[Missing
Graphic Reference].
B:
The
retention time of the principal peak in the chromatogram of the Assay
preparation
corresponds to that in the chromatogram of the Standard
preparation,
as
obtained in the Assay.
C:
The
RF
value of
the principal spot in the chromatogram of the Test
solution
corresponds to that of Standard
solution 1,
as
obtained in the test for Related
compounds.
Specific
rotation [Missing Graphic Reference]781S[Missing
Graphic Reference]:
between
+84.0[Missing Graphic Reference]
and
+87.5[Missing Graphic Reference],
determined at 20[Missing Graphic Reference].
Test
solution:
10 mg
per mL, in water.
Water,
Method
I [Missing Graphic Reference]921[Missing
Graphic Reference]:
not more
than 2.0%.
Residue
on ignition [Missing Graphic Reference]281[Missing
Graphic Reference]:
not more
than 0.7%.
Heavy
metals, Method
II [Missing Graphic Reference]231[Missing
Graphic Reference]:
0.001%.
Limit
of hydrolysis products (0.1%).
Limit
of methanol—
not more
than 0.1% of methanol is found.
Related
compounds—
(0.5%).
12
Specification
II:
Food
Chemical Code, 5th
Edition
Identification
A.
The
infrared absorption spectrum of a potassium bromide dispersion of the sample
exhibits relative maxima at the same wavelengths as those of a similar
preparation of Sucralose Standard for analytical use.1
B.
The
retention time of the major peak (excluding the solvent peak) in the liquid
chromatogram of the Sample
Preparation is
the
same as that of the Standard
Preparation obtained
in the Assay
(below).
C.
The Rf
value of the major spot in the thin-layer chromatogram of the Test
Preparation is
the
same as that of the Standard
Preparation obtained
in the test for Related
Substances (below).
Assay
Not
less
than 98.0% and not more than 102.0% of C12H19Cl3O8, calculated on the anhydrous
basis.
Hydrolysis
Products Passes
test.
Lead
Not
more
than 1 mg/kg.
Methanol
Not
more
than 0.1%.
Optical
(Specific) Rotation [_]D
20°:
Between +84.0° and +87.5°, calculated on the anhydrous basis.
Related
Substances Passes
test.
Residue
on Ignition Not
more
than 0.7%.
Water
Not
more
than 2.0%.
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