Box 3

Insulin Lispro
C 257 H 383 N 65 O 77 S 6 Mol. Wt. 5808
28 B -L-Lysine-29 B -L-proline insulin (human)
Insulin Lispro is a 2-chain peptide containing 51 amino acids. The A- chain is composed of 21
amino acids and the B- chain is composed of 30 amino acids. It is identical in primary structure
to human insulin, only differing in amino acid sequence at positions 28 and 29 of the B- chain.
Human insulin is Pro (B28), Lys (B29), whereas insulin Lispro is Lys (B28), Pro (B29). As in
human insulin, insulin Lispro contains 2 interchain disulfide bonds and 1 intrachain disulfide
bond.
Insulin Lispro is produced by a method based on recombinant DNA (r-DNA) technology. The
potency is not less than 27.0 Insulin Lispro units per mg calculated on the dried basis.
Prior to release, the following tests are carried out on each batch of the final substances.
Residual DNA
The limit is as prescribed by competent authority.
Host cell-derived protein
The limit is not more than 10 ppm.
Single-chain precursor
The limit is not more than 10 ppm. Use a suitably sensitive method.
The content of insulin Lispro is 94.0% to 104.0% of insulin Lispro (dried substance)
C 257 H 383 N 65 O 77 S 6 . By convention, for the purpose of labeling insulin lispro preparations,
0.0347mg insulin lispro is equivalent to 1 unit of insulin lispro.
Category
Hypoglycemia
Submission from NIB 1

FOREWORD
Timely and accurate diagnosis is critical to the global efforts to prevent and treat
infectious diseases. And yet, those on the front lines of this battle struggle to make do with
inadequate and antiquated testing technology.
Immunodiagnostic tests, or immunoassays used for diagnostics, have been used
extensively in any scientific disciplines and in many different ways. Such tests encompass any
analytical method which uses antibodies as reagents, the results from which assist a diagnostic
interpretation. The format of these tests has been equally varied; covering simple manual methods
monitored by radioisotopes or enzymes; fully automated systems with integrated sophisticated
detection; immunosensors; and 'dip-stick' tests
The Immuno diagnostic Kit laboratory is notified as Central Drugs Laboratory (CDL) by
Government of India vide Gazette No. 158, dated 27 th August 2002 for in-vitro diagnostic devices
for HIV, HCV and HBsAg. The laboratory has a Quality Management System in place and is
NABL Accredited in accordance with the standard ISO/IEC 17025; 2005 in the field of biological
testing. This ensures quality evaluation of diagnostic kits for safeguarding public health in the
country.
Guidance Manual: Quality Control of HBs Ag Immunodiagnostic Kits
Document ID No: NIB/IDKL/GM/03 Effective Date: 08.04.13 Page no. 3 of 37