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 |