National Institute of Biologics

COMPLIANCE: COMPARISON OF INSULIN FORMULATIONS IN PHARMACOPOEIA: EP, USP & IP

S.No	NAME OF FORMULATION AS PER PHARMACOPOEIA
S.No	European Pharmacopoeia 6.0	Indian Pharmacopoeia 2007	United States Pharmacopoeia 32
1	Insulin, Bovine	Insulin (Bovine & Porcine)-bulk	Insulin
2	Insulin, Porcine	Insulin (Bovine & Porcine)-bulk	Insulin
3	Insulin, Human	Human Insulin –HI bulk	Insulin Human
4	Insulin Injection, Biphasic	Biphasic Insulin Injection: BI+PI mix	NA
5	Insulin Injection, Biphasic isophane	Biphasic Isophane Insulin Injection HI formulation 25:75, 30:70 & 50:50	Human Insulin Isophane Suspension and Human Insulin Injection
6	Insulin Injection, Isophane	Isophane Insulin Injection HI-NPH	Isophane Insulin Human Suspension
7	Insulin Injection, Soluble	Insulin Injection, Regular	Insulin Human Injection
8	Insulin Preparations Injectable	Insulin Preparations	NA
9	Insulin Zinc Injectable Suspension	Insulin Zinc Suspension –HI lente	Insulin Human Zinc Suspension
10	Insulin Zinc Injectable Suspension (Amorphous)	Insulin Zinc Suspension Amorphous HI formulation with no defined ratio	NA
11	Insulin Zinc Injectable Suspension (Crystalline)/ Ultralente	Insulin Zinc Suspension Crystalline/ HI formulation Ultralente types	Extended Insulin Human Zinc suspension (crystalline/ Ultralente)
12	NA	Protamine Zinc Insulin injection	NA

COMPLIANCE: COMPARISON OF INSULIN ANALOGS IN PHARMACOPOEIA: EP, USP & IP

S.No	NAME OF INSULIN ANALOG AS PER PHARMACOPOEIA
S.No	European Pharmacopoeia 6.0	Indian Pharmacopoeia 2007	United States Pharmacopoeia 32
1	Insulin Aspart	NA	NA
2	Insulin Lispro	NA	Insulin Lispro
3	NA	NA	Insulin Lispro Injection

Link 2.3 contd.

AS PER IP-2007 DIFFERENT NAMES KNOWN FOR THE SAME FORMULATION

S. No	IP-2007: Formulation name	Known by different names
1	Insulin Injection- Regular	Insulin Injection
		Neutral Insulin
		Neutral Insulin Injection
		Soluble Insulin
		Plain Insulin

2	Isophane Insulin Injection HI-NPH	Isophane insulin Injection
		Isophane insulin
		Isophane insulin (NPH)

3	Biphasic Isophane Insulin Injection	1. Biphasic Isophane Insulin Injection 25:75
		2. Biphasic Isophane Insulin Injection 30:70
		3. Biphasic Isophane Insulin Injection 50:50

4	Protamine Zinc Insulin Injection	Protamine Zinc insulin Injection
4	Protamine Zinc Insulin Injection	Protamine Zinc insulin

5	Insulin Zinc suspension –HI Lente	Insulin Zinc suspension
		I.Z.S
		Insulin Zn suspension (Mixed)
		I.Z.S (Mixed)
		Insulin Lente

6	Insulin Zinc Suspension (Amorphous)	Insulin Zinc Suspensions (Amorphous)
		Amorphous I.Z.S
		Prompt Insulin Zinc Suspension

7	Insulin Zinc Suspension (Crystalline)	Insulin Zinc Suspension (Crystalline)
		Crystalline I.Z.S
		Extended Insulin Zinc suspension