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, CDMF | 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 |