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Regulatory
Regulatory aspects
In addition to a broad portfolio of standard APIs and excipients, BASF develops innovative excipients that enable you to solve your formulation difficulties. As regulatory compliance is one of our essential commitments, BASF's Regulatory Affairs professionals around the world monitor the continuously increasing regulatory requirements. Beyond the observation of these developments, BASF is also an active member in compendial working groups, associations like the International Pharmaceutical Excipients Council (IPEC), the Active Pharmaceutical Ingredients Committee (APIC) and other organizations in the pharmaceutical industry.
At BASF we are committed to making regulatory affairs easier for you: A US Drug Master File Kollicoat® IR Coating Systems (# 23187, Type IV) is already assigned by the FDA.
Kollicoat® IR
Kollicoat® IR is approved as a coating agent in medicinal products in the U.S., the EU, and in Japan. The polymer is also approved and used as a coating agent in drug products in several other countries all over the world.
A Ph. Eur. monograph entitled "Macrogol Poly(vinylalcohol) Grafted Copolymer" is published in Supplement 6.7 to the Ph. Eur.
A USP draft monograph entitled "Ethylene Glycol and Vinyl Alcohol Graft Copolym er" is published in Pharmacopoeial Forum Vol. 35, No. 2.
Pigments
Only globally approved pigments are used in Kollicoat® IR Coating Systems.
| Pigment | Sunset
Yellow | Camine | Brilliant
Blue | Titanium
dioxide | Iron oxides |
| E-Nos. | E 110 | E 120 | E 133 | E 171 | E 172 |
| FD&C-Nos. | FD&C Yellow 6 | FD&C Camine | FD&C Blue 1 | | |
| CAS-Nos. | 2783-94-0 | 1390-65-4 | 3844-45-9 | 13463-67-7 | Yellow: 51274-00-1, 20344-49-4; Red: 1309-37-1; Black: 1317-61-9, 12227-89-3; |
Pharmacopoeial
monographs | - | JPE | - | Ph. Eur.,
USP, JP | USP,
JP (Ferric oxide), JPE |
| Limits | | | | | |
| Medical prod. (EU) | q.s. | q.s. | q.s. | q.s. | q.s. |
| Medical prod. (U.S.) | q.s. | q.s. | q.s. | q.s. | ≤ 5 mg/d |
Medical prod.
(Japan) | ≤ 0.1 % (w/w) | ≤ 1.8 mg/d | ≤ 0.1 % (w/w) | ≤ 384 mg/d | Red: ≤95.4 mg/d
Yellow:≤5.67 mg/d
Black: ≤1.539 mg/d |
Why not find out more about Kollicoat® IR Coating Systems?
Further questions with regard to regulatory issues? Talk to us!
