Certificate of Analysis

Product: Castor Oil Grade: Injectable (USP-41/NF-36)

Quantity : 5kgs (5kgs X 1 Drum) Batch No: LT – 1804
Mfg Date : AUGUST 31, 2023 Expiry Date: AUGUST 30, 2025

Sr. Test
Tests Conducted Specifications
No. Value
IDENTIFICATION BY FATTY ACID COMPOSITION
01 Palmitic Acid (C:16.0)., (%) 1.16 ≤2.00
02 Stearic Acid (C:18.0)., (%) 1.29 ≤2.50
03 Oleic Acid (C:18.1)., (%) 3.71 2.50 - 6.00
04 Linoleic Acid (C:18.2., (%) 4.58 2.50 – 7.00
05 Linolenic Acid (C:18.3)., (%) 0.5 ≤1.00
06 Cis-11-Ecosenoic Acid (C:20.1)., (%) 0.33 ≤1.00
07 Ricinoleic Acid (%) 87.94 85.00 – 92.00
Cis-11-Octadecenoic Acid., or any other
08 0.49 ≤1.00
unidentified fatty acid (%)
DISTINCTION FROM MOST OTHER FIXED OILS
It is only partly soluble in solvent hexane (distinction from
Distinction from most other
09 Complies most other fixed oils), but it yields a clear liquid with an
Fixed Oils
equal volume of alcohol (foreign fixed oils)
IDENTIFICATION OF INJECTABLE CASTOR OIL BY USING ULTRAVIOLET ABSORPTION @ 270nm
10 The Absorbance @ 270nm 1.056 The absorbance is within the range of 0.70 – 1.50
ASSAY (TRIGLYCERIDE COMPOSITION)
Triricinolein (Glyceryl triricinoleate or
11 92.19 90.0
triricinoleoyl-glycerol) (RRR)
12 Diricinoleoyl-linoleoyl-glycerol., (RRL) 3.36 2.0 – 4.0
13 Diricinoleoyl-oleoyl-glycerol., (RRO) 3.78 2.5 – 5.0
14 Diricinoleoyl-stearoyl-glycerol (RRS) 0.65 0.2 – 0.8
SPECIFIC TESTS
15 Specific Gravity (gm/cm3) 0.9598 0.957 – 0.961
16 Acid Value (mg KOH/gm) 0.28 NMT 0.80
17 Hydroxyl Value (mg KOH/gm) 164.43 From 160 – 168
18 Peroxide Value (meq. O2/Kg) 1.14 NMT 5.0
19 Unsaponifiable Matter (%) 0.36 NMT 0.80
20 Water (%) 0.08 NMT 0.20
21 Saponification Value (mg KOH/gm) 180.36 176 – 182
MICROBIAL TEST
22 Bacterial Endotoxins (LAL) <0.25 Max 0.25 EU per ml
Remarks: 1. Product has been tested according to USP-41/NF-36 & complies
2. Product is filled in nitrogen atmosphere. Use nitrogen atmosphere when opening the drum.

Q. C. In-charge

Ashok Gandhi