DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)8.3 LIST OF PERMITTED AND RESTRICTED COLOURING AGENTS8.3.1 List of Permitted Colouring AgentsNO.COLOURING AGENTSCOLOURINDEXNUMBER (CI)1. Allura Red AC/ FD & C Red No.40 160352. Anthocyaninsa. Those glycosides of 2-phenylbenzopyrylium salts whichare anthocyaninsb. The following anthocyanidin aglycones :i. Pelargonidinii. Cyanidiniii. Peonidiniv. Delphinidinv. Petunidinvi. Malvidin3. Black PN (Brilliant Black BN) 284404. Brilliant Blue FCF 420905. Calcium Carbonate6. Carbo Medicinals/ Vegetalis; (Charcoal)7. Caramel8. Carmoisine (or Azorubine) 147209. Carotenoidsa. Alpha, Beta, Gamma-Caroteneb. Bixin, Noribixin, Roucouc. Annattod. Capsanthin, Capsorubin, (paprika extract)e. Lycopenef. Beta-Apo-8‟ carotenal (C 30)g. Ethyl ester of Beta-Apo-8 Carotenoic Acid (C30)i. Chlorophyllii. Copper complexes of Chlorophyll andChlorophyllins75120408207581010. Chocolate Brown HT 2028511. Cochineal or Carminic Acid, Carmine from Cochineal 7547012. Curcumin 7530013. Fast Green FCF (FD & C Green No.3) 42053National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 338
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.COLOURING AGENTSCOLOURINDEXNUMBER (CI)14. Green S (Acid Brilliant Green BS, Lissamine Green)15. Indigo Carmine (Indigotine) 7301516. Lactoflavin, Riboflavin17. Patent Blue V 4205118. Ponceau 4R (Cochineal Red A) 1625519. Quinoline Yellow 4700520. Xanthophyllsa. Flavoxanthinb. Luteinc. Cryptoxanthin (Kryptoxanthin)d. Violoxanthine. Rhodoxanthinf. Canthaxanthin21. The Following Colouring Matters Natural to Edible Fruits orVegetables:408507553022.23.a. Alkanninb. Annatto (including eye)c. Carotene (including eye)d. Chlorophylle. Flavinef. Indigog. Osageh. Orangei. Persian Berryj. Safflowerk. Saffronl. Sandalwoodm. Turmericn. or their pure coloring principles whether isolated fromsuch natural colors or produced syntheticallyBole or Iron Oxide,Carbon Black (or Vegetable Origin),Titanium DioxideThe Aluminium Salts (Lakes) of Any of the ScheduledSynthetic Dyes Approved for Use,(a) Alumina (Dried Aluminium Hydroxide)7789124. TalcNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 339
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Appearance/organoleptic(odor, color
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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