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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

CASR No. Product Name Pharmacopoeia / DMF BET Test Limit MLT Test (TAMC) Limit MLT Test (TYMC) Limit
64-19-7 Acetic acid glacial (for haemodialysis) USP, Ph.Eur, BP, IP, JP 0.5 EU/mg 100 cfu/ml 100 cfu/ml
67-64-1 Acetone USP-NF, Ph.Eur, BP, CDMF 2.0 EU/ml 100 cfu/ml 10 cfu/ml
75-05-8 Acetonitrile USDMF, CDMF 2.5 EU/ml 100 cfu/ml 10 cfu/ml
631-61-8 Ammonium Acetate Excipient Grade NMT 2.5 EU/gm NMT 100 cfu/gm NMT 100 cfu/gm
8001-54-5 Benzalkonium chloride 50% Solution USP-NF, Ph.Eur, IP, BP 0.5 EU/mg 1000 cfu/ml 100 cfu/ml
98-11-3 Benzene sulphonic acid USDMF, CDMF 2.5 EU/mg 100 cfu/g 10 cfu/g
65-85-0 Benzoic acid USP, Ph.Eur, IP 2.5 EU/g 100 cfu/g 10 cfu/g
100-51-6 Benzyl alcohol USP-NF, Ph.Eur, BP, IP, CDMF 2.5 EU/ml 100 cfu/ml 100 cfu/ml
120-51-4 Benzyl benzoate USP, Ph.Eur, BP, IP, CDMF 0.25 EU/ml 100 cfu/ml 10 cfu/ml
128-37-0 Butylated hydroxytoluene USP-NF, Ph.Eur, IP, CDMF 0.5 EU/mg 100 cfu/g 10 cfu/g
10035-04-8 Calcium chloride USP, Ph.Eur, IP 2.5 EU/g 100 cfu/g 10 cfu/g
5793-89-5 Calcium saccharate USP, CDMF 5.0 EU/g 1000 cfu/g 100 cfu/g
77-92-9 Citric acid anhydrous USP, Ph.Eur, IP 0.5 EU/mg 100 cfu/g 10 cfu/g
60-27-5 Creatinine USP-NF 2.5 EU/g 100 cfu/g 10 cfu/g
110-97-4 Diisopropanolamine USP 2.5 EU/ml 100cfu/ml 100cfu/ml
7558-79-4 di-Sodium hydrogen o-phosphate anhydrous USP, Ph.Eur, BP 2.5 EU/g 100 cfu/g 10 cfu/g
7782-85-6 di-Sodium hydrogen o-phosphate heptahydrate USP 2.5 EU/mg 100 cfu/g 10 cfu/g
10039-32-4 di-Sodium hydrogen o-phosphate dodecahydrate IP, BP, USP, Ph.Eur 2.5 EU/g 1000 cfu/g 100 cfu/g
6106-21-4 di-Sodium succinate hexahydrate USDMF, USP-NF, CDMF 6.0 EU/g 100 cfu/g 50 cfu/g
111-42-2 Diethanolamine USP-NF, IP 2.5 EU/ml 100 cfu/ml 10 cfu/ml
67-68-5 Dimethyl sulphoxide USP, Ph.Eur - 1000cfu/ml 100cfu/ml
6381-92-6 EDTA di-sodium salt dihydrate USP, Ph.Eur, IP 30 EU/g 1000 cfu/g 100 cfu/g
56-81-5 Glycerin USP, Ph.Eur, IP, BP, JP, CDMF 5.0 EU/g 100 cfu/g 10 cfu/g
79-33-4 L-(+)-Lactic acid USP-NF, BP, IP, JP, Ph.Eur 5.0 EU/g - -
108-95-2 Liquefied Phenol USP 0.2 EU/mg 100 cfu/ml 100 cfu/ml
7791-18-6 Magnesium chloride hexahydrate USP, Ph.Eur, BP, IP 2.5 EU/g 100 cfu/g 10 cfu/g
6284-40-8 Meglumine USP, Ph.Eur, BP, CDMF 1.5 IU/g 100 cfu/g 10 cfu/g
108-39-4 meta-Cresol USP, Ph.Eur, BP, CDMF 0.5 EU/mg - -
75-75-2 Methane sulphonic acid USDMF, CDMF 0.5 EU/mg 100 cfu/ml 100 cfu/ml
96-27-5 Monothioglycerol USP-NF, IP, CDMF 6.0 EU/ml 100 cfu/ml 10 cfu/ml
127-19-5 N,N-Dimethyl acetamide USDMF, Ph.Eur, CDMF 2.0 EU/ml 100 cfu/ml 10 cfu/ml
872-50-4 N-Methyl 2-pyrrolidone USP-NF, Ph.Eur 2.5 EU/ml 100cfu/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/g 100 cfu/g 10 cfu/g
7778-77-0 Potassium di-hydrogen ortho-phosphate USP-NF, Ph.Eur 2.5 EU/mg 100cfu/g 10 cfu/g
57-55-6 Propylene glycol USP, Ph.Eur, BP, IP, CDMF 0.25 EU/ml 100 cfu/ml 10 cfu/ml
6131-90-4 Sodium acetate trihydrate USP, Ph.Eur , IP, BP 0.5 EU/mg 100 cfu/g 10 cfu/g
532-32-1 Sodium benzoate USP-NF, Ph.Eur, BP, IP 2.5 EU/g 100 cfu/g 10 cfu/g
7631-90-5 Sodium bisulfite JP, CDMF 6.0 EU/g 100 cfu/g 100 cfu/g
7647-14-5 Sodium chloride USP, Ph.Eur, BP, IP, CDMF 5.0 EU/g 100 cfu/g 10 cfu/g
7558-80-7 Sodium di-hydrogen o-phosphate anhydrous USP, BP, IP 2.5 EU/g 100 cfu/g 10 cfu/g
7681-57-4 Sodium metabisulphite USP-NF, Ph.Eur, IP, CDMF 6.0 EU/g 100 cfu/g 10 cfu/g
7757-83-7 Sodium sulfite anhydrous USP-NF, Ph.Eur, BP 2.5 EU/mg 100 cfu/g 10 cfu/g
6106-24-7 Sodium Tartrate USP-NF 2.5 EU/g 100 cfu/g 10 cfu/g
110-15-6 Succinic acid USP-NF, CDMF 2.5 EU/g 100 cfu/g 10 cfu/g
75-65-0 tert - Butanol USDMF, CDMF 6.0 EU/ml 100 cfu/ml 100 cfu/ml
6132-04-3 tri-Sodium citrate dihydrate USP, Ph.Eur, IP 2.5 EU/g - -
102-71-6 Trolamine (Triethanolamine) USP-NF, Ph.Eur, CDMF 0.5 EU/mg 100 cfu/ml 10 cfu/ml
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