FAQs – on Glycerin

FAQs on Glycerine

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FAQs
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Lalit Kr. Goel

FAQs on Glycerin

Q1.      Whether Glycerin is a drug or cosmetic?

Ans:    Glycerin has dual use. It can be used as drug, cosmetic and food.

Q2:      Whether Glycerin is officially in any pharmacopoeia?

Ans:    Yes, it is official in IP and USP.

Q3:      Whether Glycerin IP can be used in food and cosmetics?

Ans:    Yes, as IP book is a standard of products for specifications and testing.

Q4:      Is any reference / document / data of dual use of API of Glycerin as the drug, food, and cosmetic?

Ans:    Yes, as per DCG(I) letter dated 05.07.2019 regarding the dual use of APIs.

To download the said letter, click here

Q5:      Whether oral Glycerin can be manufactured under form 25?

Ans:    Yes, Oral Glycerin is official in IP and can be manufactured in Oral Liquid Section only.

Q6:      Can Glycerin be manufactured in external section or for repack?

Ans:    Glycerin can be manufactured in external section if for external use only and can be repacked the same under repacking license.

Also read More FAQs, click here

Q7:      Can Glycerin product manufactured as drug claim as beauty product?

Ans:    No, it comes under the definition of cosmetics.

Q8:      What are the contaminations detected in Glycerin?

Ans:    Di-ethylene Glycol (DEG)

Q9:      What are the main instruments required for testing DEG in Glycerin?

Ans:    Gas Chromatograph is required to detect presence of DEG in Glycerin.

Q10:    When this test of DEG was introduced in IP?

Ans:    This test was introduced after JJ Hospital, Bombay tragedy in early 1980 wherein many died due to containing DEG as contamination in Glycerin.

Q11:    Name the Commission which conducted enquiry of JJ Hospital, Bombay tragedy?

Ans:    Lante Commission.

Q12:    What are the precautions for the person dealing in manufacturing of Glycerin?

Ans:    They should get Glycerin tested for contamination like DEG in their product.

To read all FAQs of the author, click here


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