Excipients for injectable formulations
For more details write to us at: excipients@finarchemicals.com

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 BET Test Limit MTL Test (TAMC) Limit MLT Test (TYMC) Limit Buffering Agents/ pH modifiers Tonicity Adjusting agents Antimicrobial/Preservative Bulking agents Solvents/ Co-Solvents Chelating Agents Antioxidants & Reducing Agents
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