SUPEROL KPO GLYCERIN, USP*/FCC/EP* SUPEROL NK GLYCERIN, USP*/FCC

SUPEROL KPO® GLYCERIN, USP*/FCC/EP*
SUPEROL NK® GLYCERIN, USP*/FCC
STAR KPO® GLYCERIN
STAR NK® GLYCERIN
MOON OU® GLYCERIN, USP*/FCC
*Excipient Use Only
Regulatory and Standards
Regulatory Items/Standards
International Nomenclature for Cosmetic
Ingredient (INCI) Name
Chemical Abstracts Number (CAS No.)
EINECS Number
US FDA Regulatory Status
Details
FDA GRAS Clearance No.:
21 CFR 182.1320
Other Food Additive Clearance: FDA 21CFR
175.105; 175.300; 175.320; 175.380; 175.390;
176.179; 176.210; 177.1210; 177.2420; 178.3120;
182.90; 182.99
P&G’s “National Drug Labelers Code” (NDC
Number)
GRAS F.E.M.A Number
Harmonized Tariff Code Number
Canadian Food and Drug Regulations, Part B
GMP
Quality Assurance
Regulatory and Standards
Glycerin
56-81-5
200-289-5
GRAS - Generally recognized as safe when used
according with good manufacturing practice.
037000
2525
2905.45
Division 16, Table XV, number 8 (glycerin)
Division 16, Table VIII, G.3 (glycerol)
Follows GMP procedures
Procter & Gamble’s USP/FCC grade (for excipient use
only) glycerin brands are manufactured in accordance
with IPEC Good Manufacturing Practices Guide for Bulk
Pharmaceutical Excipients and FCC GMP’s for food
chemicals.
COPYRIGHT © 2012 P&G CHEMICALS PAGE 1 OF 2
Drug Master File (DMF) Number
This is not applicable to our line of glycerin.
A DMF is a means of submitting Confidential Business Information (CBI) data to US FDA for use in
support of Investigational New Drug (IND) or New Drug Application (NDA) submissions, etc. A DMF is not
required by law or FDA regulation, and submission is voluntary. Since P&G Chemicals’ glycerin is for
excipient use only, P&G Chemicals has not applied for a DMF.
Compendia Conformance
As stated in the name of our products, our line of glycerin above meets the compendia requirement of
the standards below:1
Brand
SUPEROL KPO®
MOON OU®
SUPEROL NK®
Meets Standard
US Pharmacopeia*
Food Chemical Codex
European Pharmacopeia*
US Pharmacopeia*
Food Chemical Codex
Conformance Expected
British Pharmacopoeia
Japanese Pharmacopoeia
European Pharmacopoeia
British Pharmacopoeia
Japanese Pharmacopoeia
* For Excipient Use Only
1 IMPORTANT NOTE This technical product information, while believed to be accurate and reliable, is given without guarantee or warranty of any kind expressed or implied. Purchaser assumes all risk in acting on this information
provided by Procter & Gamble representatives. Individual requirements vary, and each purchaser is urged to perform their own tests, experiments and investigations in the use of Procter and Gamble products and for purposes of
determining compliance with applicable Federal, State and local laws and regulations. Nothing contained herein shall be construed as a recommendation to use any product in connection with existing patents covering any material
or its use. Moreover, no license is to be implied under any Procter & Gamble patents relating to uses of the above described chemicals other than those uses specifically mentioned herein
Regulatory and Standards
COPYRIGHT © 2012 P&G CHEMICALS PAGE 2 OF 2