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Several excipients have been developed exclusively for use in injectable formulations. These excipients maintain low level of endotoxins with the bioburden limits (BET/MLT etc) controlled as a part of specifications. The metallic impurities are also controlled to suit the application

CAS No. Product Name Pharmacopoeia BET Test Limit MLT Test (TAMC) Limit MLT Test (TYMC) Limit
67-64-1 Acetone USP-NF, Ph.Eur, BP 2.0 EU/ml 100 cfu/ml 10 cfu/ml
75-05-8 Acetonitrile USDMF 2.5 EU/ml 100 cfu/ml 10 cfu/ml
8001-54-5 Benzalkonium chloride 50% Solution USP-NF, Ph.Eur, IP 0.5 EU/mg 1000 cfu/ml 100 cfu/ml
98-11-3 Benzene sulphonic acid USDMF 2.5 EU/mg 100 cfu/gm 10 cfu/gm
65-85-0 Benzoic acid USP, Ph.Eur, IP 2.5 EU/gm 100 cfu/gm 10 cfu/gm
100-51-6 Benzyl alcohol USP-NF,BP,IP 2.5 EU/ml 100 cfu/ml 10 cfu/ml
120-51-4 Benzyl benzoate USP,Ph.Eur,BP,IP 0.25 EU/ml 100 cfu/ml 10 cfu/ml
128-37-0 Butylated hydroxytoluene USP-NF,Ph.Eur,IP 0.5 EU/mg 100 cfu/gm 10 cfu/gm
10035-04-8 Calcium Chloride USP, Ph.Eur, IP 2.5 EU/gm 100 cfu/gm 10 cfu/gm
60-27-5 Creatinine USP-NF 2.5 EU/gm 100 cfu/gm 10 cfu/gm
6106-21-4 Di - Sodium succinate hexahydrate US DMF 6.0 EU/gm 100 cfu/gm 50 cfu/gm
111-42-2 Diethanolamine USP-NF, IP 2.5 EU/ml 100 cfu/ml 10 cfu/ml
6381-92-6 EDTA di-sodium salt USP,Ph.Eur,IP 30 EU/g 1000 cfu/gm 100 cfu/gm
56-40-6 Glycine USP, Ph.Eur, IP    
50-21-5 Lactic acid USP-NF, BP, IP 5.0 EU/gm  
7791-18-6 Magnesium Chloride USP,Ph.Eur, BP, IP 2.5 EU/gm 100 cfu/gm 10 cfu/gm
69-65-8 Mannitol USP,Ph.Eur,BP, IP 2.5 IU/gm 100 cfu/gm 10 cfu/gm
108-39-4 meta - Cresol USP,Ph.Eur,BP 0.5 EU/mg  
75-75-2 Methane sulfonic acid USDMF** 0.5 EU/mg 100 cfu/ml 100 cfu/ml
96-27-5 Monothioglycerol USP-NF,IP 6.0 EU/ml 100 cfu/ml 10 cfu/ml
127-19-5 N,N-Dimethyl acetamide USDMF 2.0 EU/ml 100 cfu/ml 10 cfu/ml
108-95-2 Phenol USP,Ph.Eur,IP 0.2 EU/mg 1000 cfu/ml 1000 cfu/ml
25322-68-3 Polyethylene glycol 400 USP-NF, Ph.Eur 2.5 EU/ml 100 cfu/ml 10 cfu/ml
7447-40-7 Potassium chloride USP, Ph.Eur, BP, IP 2.5 EU/gm 100 cfu/gm 10 cfu/gm
57-55-6 Propylene glycol USP,Ph.Eur,BP,IP 0.25 EU/ml 100 cfu/ml 10 cfu/ml
532-32-1 Sodium benzoate USP-NF, Ph.Eur, BP, IP 2.5 EU/gm 100 cfu/gm 10 cfu/gm
7647-14-5 Sodium chloride USP,Ph.Eur, IP, BP 5.0 IU/gm 100 cfu/gm 10 cfu/gm
7558-80-7 Sodium di-hydrogen o-phosphate anhydrous USP, IP 2.5 EU/gm  
7681-57-4 Sodium metabisulphite USP-NF, Ph.Eur, IP 6.0 EU/gm 100 cfu/gm 10 cfu/gm
7757-83-7 Sodium sulphite anhydrous USP,Ph.Eur 2.5 EU/mg  
110-15-6 Succinic acid USP-NF 2.5 EU/gm  
75-65-0 tert - Butanol USDMF 6.0 EU/ml 100 cfu/ml 10 cfu/ml
6132-04-3 tri-Sodium citrate dihydrate USP, Ph.Eur, IP 2.5 EU/gm  
102-71-6 Trolamine (Triethanolamine) USP-NF, Ph.Eur 0.5 EU/mg 100 cfu/ml 10 cfu/ml
COA Product Catalogues Product Search Parenteral Applications
COA Product Catalogues Product Search Parenteral Applications