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 |
