SPECIFICATION OF CEFTRIAXONE SODIUM USP
S.NO TESTS SPECIFICATION AS PER USP44 NF39
Description White to yellowish Orange Crystalline Powder hygroscopic.
Solubility Freely soluble in water, sparingly soluble in methanol, very slightly soluble in
anhydrous ethanol
3 Identification
A) By IR The test spectrum should match with the reference standard spectrum.
B)HPLC (ASSAY) The chromatogram of the Assay preparation obtained as directed in the Assay
exhibits a major peak for ceftriaxone, the retention time of which corresponds to
that exhibited in the chromatogram of the Standard preparation obtained as
directed in the Assay.
C) Sodium Test It gives reaction) of Sodium
4 Crystallinity Meets the requirments to compliance with USP
5 Particulate Matter
>10 m NMT 6000/container
(By Light Obscuration
>25 m NMT 600/container
Method)
6 pH between 6.0 and 8.0 in a solution (1 in 10)
7 Water between 8.0% and 11.0%.
8 Bacterial endotoxins It contains not more than 0.20 USP Endotoxin Unit per mg of ceftriaxone
9 Sterility Test It meets the requirements when tested as directed for Membrane Filtration under
Test for Sterility of the Product to be Examined
10 Organic impurities Acceptance Criteria NMT (%)
Deacetylcefotaxime lactonea NMT 0.5 %
7-Aminocephalosporanic acid NMT 0.5 %
b, c
Ceftriaxone triazine analogd NMT 1 %
Ceftriaxone NMT 0.2 %
benzothiazolyloximee
Deacyl ceftriaxone NMT 0.5 %
Ceftriaxone —
Ceftriaxone E-isomer NMT 0.5 %
Any individual unspecified NMT 0.2 %
impurity
Total impurities NMT 2.5 %
11 Ceftriaxone Sodium USP Not less than 795 μg of ceftriaxone per mg, calculated on the anhydrous basis
Analysed by (QC Head) Approved by (QA Head) .
(Sign.) (Sign.)
Certificate of Analysis of Raw Materials
(Under the Drugs & Cosmetics Act and Rules thereunder-1940)
Raw Material Ceftriaxone Sodium USP Report No: R/12/21/50
Name
Batch No ABIA21074 Quantity Purchased 50 kg
Mfg Date 09/ 2021 Expiry date 08/2026
Manufactured by Aurobindo Pharma Limited Supplied by Aurobindo Pharma Limited
Date of Receipt 22-12-2021 Date of Release 22-12-2021
Sampled By Sarbjeet Kaur Sample Qty 5 gm
ANALYTICAL DATA
S.NO TESTS SPECIFICATION RESULTS
Description White to yellowish Orange Crystalline Powder hygroscopic. White Crystalline
Powder
Solubility Freely soluble in water, sparingly soluble in methanol, very slightly soluble in Complies
anhydrous ethanol
3 Identification
A) By IR The test spectrum should match with the reference standard spectrum. Positive for
Ceftriaxone
B)HPLC (ASSAY) The chromatogram of the Assay preparation obtained as directed in the Assay Positive for
exhibits a major peak for ceftriaxone, the retention time of which corresponds Ceftriaxone
to that exhibited in the chromatogram of the Standard preparation obtained as
directed in the Assay.
C) Sodium Test It gives reaction) of Sodium Positive for Sodium
4 Crystallinity Meets the requirements to compliance with USP Meets the
requirements
5 Particulate Matter >10 m NMT 6000/container Complies
(By Light Obscuration Method) >25 m NMT 600/container
6 pH between 6.0 and 8.0 in a solution (1 in 10) 7.1
7 Water between 8.0% and 11.0%. 10.4%
8 It contains not more than 0.20 USP Endotoxin Unit per mg of Within Limits
Bacterial endotoxins
ceftriaxone
9 Sterility Test It meets the requirements when tested as directed for Membrane Filtration Sterile
under Test for Sterility of the Product to be Examined
10 Organic impurities Acceptance Criteria NMT (%)
Deacetylcefotaxime lactonea NMT 0.5 % 0.3 %
7-Aminocephalosporanic acid b, c NMT 0.5 % 0.4 %
Ceftriaxone triazine analogd NMT 1 % 0.7 %
Ceftriaxone benzothiazolyloximee NMT 0.2 % 0.1 %
Deacyl ceftriaxone NMT 0.5 % 0.2 %
Ceftriaxone — 0.2 %
Ceftriaxone E-isomer NMT 0.5 % 0.1 %
Any individual unspecified impurity NMT 0.2 % 0.3 %
Total impurities NMT 2.5 % 2.3 %
11 Assay Limits Result %age Protocol
Ceftriaxone Sodium USP Not less than 795 μg of 804 μg of 101.13% USP44 NF 39
ceftriaxone per mg, calculated ceftriaxone per On dried
on the anhydrous basis mg, substance
Remark:- In the opinion of the undersigned, the sample submitted above is of standards quality with respect to the above tests as per
USP specification
Checked by: Approved by
Analytical Chemist Q.C.Head
SPECIFICATION OF CEFTRIAXONE FOR INJECTION USP
S.NO TESTS SPECIFICATION AS PER USP44 NF39
1 Description White to yellowish Orange Crystalline Powder hygroscopicfilled in clear glass
vial
2 Solubility Freely soluble in water, sparingly soluble in methanol, very slightly soluble in
anhydrous ethanol
3 Identification
A) By IR The test spectrum should match with the reference standard spectrum.
B)HPLC (ASSAY) The chromatogram of the Assay preparation obtained as directed in the Assay
exhibits a major peak for ceftriaxone, the retention time of which corresponds to
that exhibited in the chromatogram of the Standard preparation obtained as
directed in the Assay.
C) Sodium Test It gives reaction) of Sodium
4 Crystallinity Meets the requirments to compliance with USP
5 Uniformity of dosage units meets the requirements
6 Clarity and color of Solution may clear
constituted solution
7 Particulate Matter
>10 m NMT 6000/container
(By Light Obscuration
>25 m NMT 600/container
Method)
8 pH between 6.0 and 8.0 in a solution (1 in 10)
9 Water between 8.0% and 11.0%.
10 Bacterial endotoxins It contains not more than 0.20 USP Endotoxin Unit per mg of ceftriaxone
11 Sterility Test It meets the requirements when tested as directed for Membrane Filtration under
Test for Sterility of the Product to be Examined
12 Organic impurities Acceptance Criteria NMT (%)
Deacetylcefotaxime lactonea NMT 0.5 %
7-Aminocephalosporanic acid NMT 0.5 %
b, c
Ceftriaxone triazine analogd NMT 1 %
Ceftriaxone NMT 0.2 %
benzothiazolyloximee
Deacyl ceftriaxone NMT 0.5 %
Ceftriaxone —
Ceftriaxone E-isomer NMT 0.5 %
Any individual unspecified NMT 0.2 %
impurity
Total impurities NMT 2.5 %
13 Ceftriaxone Sodium USP Not less than 776 μg of ceftriaxone per mg, calculated on the anhydrous basis or
90% to 115% of Ceftriaxone
Analysed by (QC Head) Approved by (QA Head) .
(Sign.) (Sign.)
Certificate of Analysis of Finished Product
(Under the Drugs & Cosmetics Act and Rules thereunder-1940)
Brand Name CEFAZONE-NP 1GM Report No: F/01/21/13
Generic Name Ceftriaxone for Injection USP
Batch No A12906 Batch Size 1 lac vials
Mfg Date JAN 2021 Expiry date DEC 2022
Date of Receipt 05-01-2021 Date of Release 05-01-2021
Sampled By Sample Qty 6 Vials
ANALYTICAL DATA
S.NO TESTS SPECIFICATION AS PER USP44 NF39 RESULTS
1 Description White to yellowish Orange Crystalline Powder hygroscopic filled in clear Complies
glass vial
2 Solubility Freely soluble in water, sparingly soluble in methanol, very slightly soluble in Complies
anhydrous ethanol
3 Identification
A) By IR The test spectrum should match with the reference standard spectrum. Positive for
Ceftriaxone
B)HPLC (ASSAY) The chromatogram of the Assay preparation obtained as directed in the Assay Positive for
exhibits a major peak for ceftriaxone, the retention time of which corresponds Ceftriaxone
to that exhibited in the chromatogram of the Standard preparation obtained as
directed in the Assay.
C) Sodium Test It gives reaction) of Sodium Positive for
Sodium
4 Crystallinity Meets the requirments to compliance with USP Meets the
requirements
5 Uniformity of dosage units Meets the requirements Within Limits
Clarity and color of constituted Solution may clear Clear
6 solution
7 Particulate Matter >10 m NMT 6000/container Complies
(By Light Obscuration Method) >25 m NMT 600/container
8 pH between 6.0 and 8.0 in a solution (1 in 10) 7.1
9 Water between 8.0% and 11.0%. 10.4%
10 It contains not more than 0.20 USP Endotoxin Unit per mg of Within Limits
Bacterial endotoxins
ceftriaxone
11 Sterility Test It meets the requirements when tested as directed for Membrane Filtration Sterile
under Test for Sterility of the Product to be Examined
12 Organic impurities Acceptance Criteria NMT (%)
Deacetylcefotaxime lactonea NMT 0.5 % 0.3 %
7-Aminocephalosporanic acid b, c NMT 0.5 % 0.4 %
Ceftriaxone triazine analogd NMT 1 % 0.7 %
Ceftriaxone benzothiazolyloximee NMT 0.2 % 0.1 %
Deacyl ceftriaxone NMT 0.5 % 0.2 %
Ceftriaxone — 0.2 %
Ceftriaxone E-isomer NMT 0.5 % 0.1 %
Any individual unspecified impurity NMT 0.2 % 0.3 %
Total impurities NMT 2.5 % 2.3 %
13 Assay Limits Result %age Protocol
Claim: Each Vial contains Not less than 776 μg of 794 μg of 102.31% USP44 NF 39
Ceftriaxone Sodium USP ceftriaxone per mg, 90 % to ceftriaxone per On dried
Eq to Ceftriaxone 1 gm 115 % of ceftriaxone mg, substance
calculated on the anhydrous
basis
Remark:- In the opinion of the undersigned, the sample submitted above is of standards quality with respect to the above tests as per
USP specification
Checked by: Approved by
Analytical Chemist Q.C.Head
