For Restricted Circulation Only
Nixi Laboratories Pvt. Ltd.
VPO: Mouza Ogli, Sadhora Road, Kala Amb (H.P.)
Quality Control Department
STANDARD TEST SPECIFICATION
Title: ADRENALINE BITARTRATE IP
Specification No. QC/RM/STS/170 Reference STP No.: QC/RM/STP/170
Supersede No.: Nil Revision No.: 00
Effective date: 11/03/2022 Review Date: 10/03/2024
Sr. No. TEST SPECIFICATION
1. Description A white or greyish-white, crystalline powder;
odourless. It darkens on exposure to air and light,
decomposition being faster in the presence of
moisture and at higher temperatures.
2. Solubility Freely soluble in water; slightly soluble in
ethanol (95 per cent); practically insoluble in
chloroform and in ether.
3. Identification
(A) Determine By Infrared Compare the spectrum with that obtained with
Absorption Spectrophotometer adrenaline WS or with the reference spectrum of
adrenaline.
(B) Determine By Ultraviolet and Absorbance at about 279 nm is about 0.4
Visible Absorption Spectrophotometry
(C) By Chemically (Reaction ‘C’ of A dark blue colour that changes to red when the
Tartrate) solution is cooled and poured into water is
produced.
4. Appearance of Solution The solution is not more opalescent than
opalescence standard OS2 and not more
intensely coloured than reference solution BYS4
5. Specific Optical Rotation -50.0º to -54.0º on dried substance basis
6. pH 2.8 to 4.0
7. Related substance (By HPLC)
(A) The area of any Impurity:
(i) At Relative retention time of about Not more than 0.2 %
3.2
(ii) At Relative retention time of about Not more than 0.2 %
0.8 and 1.3
(B) Any Secondary Impurity Not more than 0.1 %
(C) The Sum of Areas of All The Not more than 0.6 %
Secondary Impurity
8. Phenones Absorbance at the maximum at about 310 nm,
not more than 0.10 on the dried basis
Prepared By Checked By Approved By
Name Sachin Kumar Parul Mehandiratha Pramod Kumar
Designation Officer QC Executive QC [Link] QC
Signature
Date
Format No.: NL/QC/032/F02-02 Page 1 of 2
For Restricted Circulation Only
Nixi Laboratories Pvt. Ltd.
VPO: Mouza Ogli, Sadhora Road, Kala Amb (H.P.)
Quality Control Department
STANDARD TEST SPECIFICATION
Title: ADRENALINE BITARTRATE IP
Specification No. QC/RM/STS/170 Reference STP No.: QC/RM/STP/170
Supersede No.: Nil Revision No.: 00
Effective date: 11/03/2022 Review Date: 10/03/2024
9. Sulphated Ash Not more than 0.1 %
10. Loss on Drying Not more than 0.5 %
11. Assay (By Micro)
98.0% to101.0% on dried basis.
Abbreviations:
IP: Indian Pharmacopeia STP: Standard Testing Procedure
STS: Standard Test Specification QC: Quality Control
RM: Raw Material No.: Number
NA: Not Applicable CCF: Change Control Format
HPLC: High Performance Liquid Chromatography
Change History:
Effective Date Version no. Superseded no. CCF no. Reason for Review
00 Nil NA New documents
Prepared By Checked By Approved By
Name Sachin Kumar Parul Mehandiratha Pramod Kumar
Designation Officer QC Executive QC [Link] QC
Signature
Date
Format No.: NL/QC/032/F02-02 Page 2 of 2