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 PRODUCT SPECIFICATIONS
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Alendronic Acid | 4 Amino Butyric Acid | Benzil | Benzillic Acid | Benzoin | Caproic Anhydride | Gallic Acid | Heptanoic Anhydride
Potassium Hydroxide Powder | Silver Nitrate | 5- Chloro 4- Amino –2,1,3 (Benzothiadiazole) |
Ethylene Urea | N- Acetyl Ethylene Urea | 4-BROMO ANILINE | Risedronic Acid | Acetyl Ethylene


PHARMA DRUG INTERMEDIATES SPECIFICATION

Find attached specification for 4 Amino Butyric Acid, Risedronic Acid, Fluorescein Acid, Ethylene Urea, Acetyl Ethylene Urea & 4 Bromoaniline.


ALENDRONIC ACID
Specification For : Alendronic Acid
J P N Pharma Pvt. Ltd
CAS No. 66376-36-1
CAS Name (4-Amino-1-hydroxybutylidene)bisphosphonic acid
Additional Name a-hydroxy-d-aminobutylidenediphosphonic acid
Molecular wt. 249.10
Chemical Composition C H NO P
4  13  17  2
Test Specification
Description White Crystalline Powder
Identification A. I. R. TEST
Heavy Metals Limit : Max .20PPM
Loss on Drying (By Kf) 1% W/W
4-Aminobutanoic acid (by TLC) Limit : Max.0.5%
Phosphite Limit : Max.0.5%
Assay (Titration) Limit: 98% to 102%




4 Aminobutyric Acid
Specification For : 4- Amino butyric Acid OR 4- Aminobutanoic Acid
CAS. NO. [56-12-2 ]
Molecular Formula C4H9NO2
Molecular Weight 103.12
Test Specification
Description White crystalline powder.
Identification Chemical Test
Clarity of Solution It should be clear
pH Limit : 6.5 -7.5
Heavy Metals Limit : Max. 10 PPM
Chloride Limit : Max. 40 PPM
Sulphate Limit : Max.50 PPM
Arsenic Limit : Max. 1 PPM
Ca2+ No Opalescence
Melting Point Limit : 1970 C - 2040C
Loss of Drying Limit : Max. 0.5%
Residue on Ignition Limit : Max. 0.1%
Assay Limit : Min. 99%




BENZIL
Specification For : Benzil
Test Specification
Description Light yellow crystals
Solubility Passes in Ethanol
Melting Point Limit: 93 0 C to 96 0 C
Tlc Passes in single spot
Extra Tests Performed On Benzil
In 50 % Solution of Caustic Soda No suspended impurity seen after half an hour of string (clear water white solution)
In Susphuric Acid 0.10 gms in 5 ml shows light yellow colour for the hour (no green colour or blue colour found)




BENZILLIC ACID
Specification For : Benzilic Acid
CAS NO 76-93-7
Molecular Formula C H O
14 12 3
Molecular Weight 228.24
Synonym {Hydroxy {Phenylbenzene Acetic Acid Or Diphenylalycolic Acid}
Test Specification
Description Almost white crystalline powder, odourless, taste bitter
Solubility Slightly soluble in cold water, Highly soluble in hot water, Alcohol, Ether
Melting Point Limit: 148 0 C to 150 0 C
Loss On Drying Max. 1.0 %
Sulphated Ash Max. 0.1 %
Chloride (CL) Max. 0.01 %
Sulphate (SO) 4 Max. 0.02 %
Assay Min. 98.0 %




Enanthic Anhydride
Specification For : Heptanoic Anhydride
CAS NO 626 - 27 - 7
Extended Formula [CH3(CH2)5CO]2O
Empirical Formula C14H26O3
Formula Weight 242.36
Test Specification
Description Very faintly yellow clear liquid
Solubility Colourless, Clear
Solubility (Method) 1 G in 10 ML ETOH
Iodine Value Limit : Max.1 %
Free Acidity As (Heptanoic Acid) Limit : Max.1.5 %
Density D 25 0.905
Assay Limit : Min.98 %




BENZOIN
Specification For : Benzoin
Chemical Name Acetophenone, 2-Hydroxy-2-Phenyl Or
Ethanone, 2-Hydroxy-1, 2-Diphenyl Or
A-Hydroxy-A-Phenylacetophenone
CAS No. 119-53-9
Formula C14H12O2
Test Specification
Description Creamish crystalline
Solubility Soluble in Acetone
Melting Point Limit 132 0 C to 136 0 C
TLC Single spot
Chromatography Purity :-
Single Maximum Impurity Limit : Max. 1 %
Total Impurity Limit : Max. 3 %
Loss on Drying w/w Limit Max. 1%
Assay (by G.C) Above 97%




CAPROIC ANHYDRIDE
Specification For : N - Caproic Anhydride
Synonym Hexadecanoic Anhydride
CAS No. 2051-49-2
Extended Formula [CH3 (CH2)4CO] 20
Empirical Formula C12H22O3
Test Specification
Description Very faintly yellow clear liquid
Acid Value (As Free Caproic Acid) Limit: Max.1%
Iodin Value Limit: Max. 1 %
Density D (20/4) Limit : 0.920 to 0.928
Reflective Index N (20/D) 1.429
Assay Limit: Min.97%




GALLIC ACID
Specification For : Gallic Acid
Test Specification
DESCRIPTION White to off white crystalline powder.
SOLUBILITY One gm dissolves in 87ml water, 3ml boiling water, 6ml alcohol, 100 ml ether, 10ml glycerol, 5 ml acetone, practically insoluble in benzene chloroform, pet. ether.
MELTING POINT Limit : 258-265°C
ARSENIC Limit : NMT 4 PPM
RELATED SUBSTANCE(TLC) Complies.
LOSS ON DRYING Limit : Max. 10% w/w (for Monohydrate) & Max. 1% w/w (for anhydrous)
RESIDUE ON IGNITION Limit : Max. 0.1%
HEAVY METALS Limit : NMT 20 PPM
PURITY BY ACID TITRATION Limit : Min. 99.5%




HEPTANOIC ANHYDRIDE
CAS NO 626- 27- 7
EXTENDED FORMULA (CH3(CH2)5CO)2O
EMPIRICAL FORMULA C14 H 2605
FORMULA WEIGHT 242
APPEARANCE VERY FAINTLY YELLOW CLEAR LIQUID
ASSAY MINIMUM 98%
IODINE VALUE 1%
FREE ACID 1.50%
DENSITY D 25 0.905
SOLUBILITY COLOURLESS CLEAR
SOLUBILITY (METHOD) 1 G IN 10 ML ETOH




2,3,4-Trimethoxy Benzaldehyde
Specification For : 2,3,4-Trimethoxy Benzaldehyde
CAS No. 2103-57-3
Molecular Formula (CH30)3C6H2CHO
Molecular Weight 196.20
Test Specification
Description Off white to pale yellow crystalline powder
Solubility Should be soluble in MDC and toluence
Melting Range Limit : 390C to 420C
Moisture by KF Max. 0.5%
Assay (by GC) Limit :Min. 99%
Storage Store in air tight containers




POTASSIUM HYDROXIDE POWDER
Specification For : Potassium Hydroxide Powder
Test Specification
Caustic Potash as KOH Limit :Min. 87%
Potassium Carbonates (AS K2CO3) Limit : Max. 1%
Potassium Chlorides (AS KCL) Limit : Max. 300 PPM
Iron as Fe+++ Limit : Max. 20 PPM




SILVER NITRATE
Specification For : Silver Nitrate
Test Specification
Description White crystalline Powder.
Solubility Freely soluble in water
Water Insoluble matter Limit : 0.003%
Chloride Limit : 0.0005%
Sulphate Limit : 0.0025%
Bismuth Limit : 0.0005%
Calcium Limit :0.001%
Copper Limit : 0.0002%
Iron Limit : 0.003%
Lead Limit : 0.0005%
Magnesium Limit : 0.001%
Potassium Limit : 0.01%
Sodium Limit : 0.002 %
Loss On Drying Limit : 0.01%
Assay Limit : Min. 99.9%




5- CHLORO 4- AMINO –2,1,3 (BENZOTHIADIAZOLE)
Specification For : 5- Chloro 4- Amino ?2,1,3 (benzothiadiazole)
Test Specification
Appearance Yellow to brownish yellow coloured powder.
Melting Point Limit : 86-92º C
Loss on Drying Limit : Max. 0.5 %
TLC Single spot approx. 98%
No single impurity Max. 1%




Ethylene Urea
Certificate of Analysis For : Ethylene Urea (Anhydrous)
Test Specification
Description White to pale yellow free flowing powder.
Alkalinity as Free EDA Limit: Max.0.1%
Melting Point Limit : Min. 131o C
PH of 10 % Aqueous Solution Limit : Limit: 6.0 ? 8.0
Total Moisture Limit : Max. 1%
Water Insoluble Limit: Max 0.05%




N- Acetyl Ethylene Urea
Specification For : N- Acetyl Ethylene Urea
CAS No. 5391-39-9
Molecular Formula C5H8N2O2
Molecular Weight 128
Test Specification
Description White to straw crystalline powder.
Solubility Soluble in methanol
Melting Range Limit: 175 0 C to 184 0 C




4 Bromoaniline
Specification For : 4-BROMO ANILINE (P-Bromoaniline, 4-Bromobenzeneamine)
CAS No. 106-40-1
Molecular Formula C6 h6br n
Molecular Weight 172.02
Test Specification
Description Off white to to cream colour powder
Solubility Freely soluble in alcohol
Melting Point Limit : 600 C to 63 0 C
Moisture Limit: Max. 0.5%
Assay (By G.C.) Limit: Min. 98%




RISEDRONIC ACID
Specification For : Risedronic Acid
J P N Pharma Pvt. Ltd
CAS No: 105462-24-6
Chemical Name [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid
Molecular formula C7H11NO7P2
Molecular Weight 283.11
Test Specification
Description White to off white Crystalline powder
Identification A) Infra Red Absorption Spectrum
Solubility Soluble in 0.1 M sodium hydroxide, Sparingly soluble in water, insoluble in organic solvents
Clarity & colour of solution (1% w/v in water) Clear & Colourless solution
pH (1% in Water) Limit : 3.7 ? 4.8
Loss on Drying Limit : 12.2% - 13.5% w/w/
Heavy Metals Limit : Max. 20 ppm
Residual Solvents
Monochloro Benzene
Methanol
Chloroform 		Limit :
2000 ppm
1500 ppm
1000 ppm
Related Substances
a) Pyridine ? 3-actic acid (by HPLC)
b) Phosphite content (by tritrimetic 		Max. 0.2%
Max. 1%
Assay % (by HPLC) (On anhydrous basis) Limit : Min. 99%






Alendronic Acid | 4 Amino Butyric Acid | Benzil | Benzillic Acid | Benzoin | Caproic Anhydride | Gallic Acid | Heptanoic Anhydride
Potassium Hydroxide Powder | Silver Nitrate | 5- Chloro 4- Amino –2,1,3 (Benzothiadiazole) |
Ethylene Urea | N- Acetyl Ethylene Urea | 4-BROMO ANILINE | Risedronic Acid | Acetyl Ethylene


 OUR PRODUCTS
  Active Pharma Ingredients  Pharma Intermediates  Under Developments
 PRODUCT SPECIFICATIONS
  Active Pharma Ingredients  Pharma Intermediates  

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