As envisioned by our Founder, Mentor and Guide, Late chairman Mr. K. K. Vithani, we have consciously embarked on and adopted single product policy. We have made all the right efforts to be the best in class and leader in the manufacturing of Paracetamol / Acetaminophen.
The decision to manufacture single product could be attributed to the reason that Paracetamol is the safest and the cheapest API for analgesic and antipyretic usage with largest volumes. We provide Paracetamol / Acetaminophen in powder form for Tablets, Suspension (liquid syrups), Encapsulation, Suppository and Injectable.
A
POWDERS
CODE
APPLICATION
1
Powder
P 101
Granulation for Tablets
2
Fine Powder
P 102
Liquid Syrup
B
COARSE POWDERS
1
Dense
P 201
Granulation for Tablets
2
High Dense
P 202
Capsule Grade
3
Free Flowing
P 203
Encapsulation Grade
C
ANY TAILOR MADE SPECIFICATION
D
BATCH SIZE
4 MT TO 8 MT -helps reduce
In-House Laboratory Work
Test No.
Name of Test
IP
BP/EP
USP
1.
Description/Appearance
White Crystals or White Crystalline Powder
White, or almost white, Crystalline Powder
White, odorless, Crystalline Powder.
2.
Solubility
Sparingly soluble in Water
Sparingly soluble in Water
-
Freely soluble in ethanol
Freely soluble in Ethanol (96%)
Freely soluble in Ethyl Alcohol
Very slight soluble in Methylene chloride
Very slight soluble in Methylene chloride
-
-
-
Soluble in Boiling Water and in 1N NaOH.
3.
Melting Point
-
-
-
4.
Identification
(A) The absorbance at 249 nm is about 0.44 (B) A violet color develops which does not turn to red. (C) Gives the reaction of acetyl groups. (D) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard.
(A)Result-A Melting Point - 168°C to 172°C. Result-B
The absolute difference between the melting point mixture and the value obtained in Determination A (Result-A) is not greater than 2°C (B) The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Paracetamol working standard.
(A)By IR:
The Infrared absorption spectrum of substance being examined must be concordant with the IR spectrum obtained from Acetaminophen working standard. (B) By HPLC:
The retention time of the major peak obtained in sample solution corresponds to that obtained in the standard solution, as described in the test of assay.
Related Substance
Impurity J
Max. 10 ppm
Max. 10 ppm
-
Impurity K
Max. 50 ppm
Max. 50 ppm
-
Impurity F
Max. 0.05 %
-
-
Unspecified Impurity
-
Max. 0.05 %
Max. 0.05 %
Total Impurities
Max. 0.1 %
Max. 0.2 %
NMT 0.1 %
Any other Impurity
Max. 0.05 %
-
-
Organic Impurities
Acetaminophen Related Compound B
-
-
NMT 0.05%
Acetaminophen Related Compound C
-
-
NMT 0.05%
Acetaminophen Related Compound B
-
-
NMT 0.05%
Acetaminophen Related Compound J
-
-
NMT 0.001%
5.
Free 4-Aminophenol
-
-
NMT 0.005%
6.
Loss on Drying (at 105°C)
Maximum 0.5% w/w
Maximum 0.5 % w/w
Maximum 0.5% w/w
7.
Residue on Ignition
-
-
NMT 0.1%
8.
Heavy Metals
NMT 10 ppm
-
-
9.
Sulphated Ash
NMT 0.1 % w/w
NMT 0.1 % w/w
-
10.
Assay
99.0 % to 101.0 % w/w C8H9NO2 (On dried basis)
99.0 % to 101.0 % w/w C8H9NO2 (On dried basis)
98.0% - 102.0%, (C8H9NO2 on the dried basis)
GLACIAL ACETIC ACID SPECIFICATON
SR.NO
TEST
SPECIFICATION
1
Appearance
Clear, Colorless volatile Liquid
2
Freezing point
NLT 15.7 °C
3
Acetic acid(purity)
NLT 99.5 %W/W
4
Formic acid (%w/w)
NMT 0.10 %
5
Chloride (ppm)
MAX 15 ppm
6
Color (APHA)
NMT 15 Hazen
7
Acetaldehyde percent
NMT 0.05%
8
Moisture (by Karl-Fischer)
NMT 0.5 %
9
Propionic Acid % (By GC)
NMT 0.05%
10
Sulphate
NMT 5 ppm
11
Iron content
NMT 1 ppm
12
Specific gravity at 27°C
1.046 - 1.050 g/ml
13
Permanganate time (Minutes)
NLT 5
14
Any other single unknown impurity (% area by GC.)
NMT 0.02 %
We have Two State of the Art Manufacturing facilities with an installed production capacity of 16500 MT Annually.