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Alendronic Acid | 4 Amino Butyric Acid | Ibandronic Acid | 3-(N-methylpenthylamino) propionic acid HCl | 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%




Ibandronic Acid
Specification For : Ibandronic Acid
Test Specification
Description White flowing powder
Solubility Soluble in water, slight soluble in methanol
Clarity of Solution Colourless, Clarify
Heavy Metals Limit : Max. 20PPM
Phosphite Limit : Max. 0.3%
Phosphate Limit : Max. 0.3%
Relative Substance Any single impurity : Max. 0.3% Total Impurity : Max. 1%
Assay Limit : 98% to 102%




3-(N-methylpenthylamino) propionic acid HCl
Specification For : 3-(N-methylpenthylamino) propionic acid HCL
CAS No. 625120-81-2
Chemical Composition C9H19NO2 HCl
Test Specification
Description White Crystalline or crystalline Powder
Melting Point Limit : 98 0 -100 0 C
Relative Substance Total Impurity : Max. 0.5% Any single impurity : Max. 0.2%
Residue on ignition Limit : Max.0.2%
Loss on Drying Limit : Max. 0.2%
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 %




1-(6-Methylpyridine-3-yl)-2{(4-methylsulphonyl)phenyl]ethanone (ketosulphone)
Specification For : 1-(6-Methylpyridine-3-yl)-2{(4-methylsulphonyl)phenyl]ethanone (ketosulphone)
Test Specification
Description White to creamish powder
Melting Point 180°C – 186 °C
Water content NMT 0.5 %
Assay by HPLC NLT 93.0 %




2-CHLORO-1,3-BIS(DIMETHYLAMINO)TRIMETHINIUM HEXAFLUOROPHOSPHATE
Specification For : 2-CHLORO-1,3-BIS(DIMETHYLAMINO)TRIMETHINIUM HEXAFLUOROPHOSPHATE
Test Specification
Description Cream to pale yellow crystalline Powder.
Melting Point Limit 120 ° C to 130 ° C
Water content NMT 0.5 %
Chromatographic Purity by HPLC NLT 98.00 %




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%




Methyl Gallate
Test Specification
Description White crystalline powder, odourless
Impurities Complies as single spot seen in TLC (No unconverted Gallic Acid spot)
Solubility Soluable in hot water Alcohol, Menthanol & Ether
Melting Point Limit: 2020 C
TLC Single spot
Chromatographic Complies
Assay Limit: Min. 98%




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%




5-{4-[2-(5-Ethyl-2-pyridyl)ethoxy]benzyl]2-amino-4-Thiazolidine [Pio Imino Compound]
Molecular Formula C19H21N3O2S
Molecular Weight 355.45
Test Specification
Description Off white to buff yellow solid.
Identification (By HPLC) The retention time of the principal peak (Imino Compound Peak) obtained with sample solution is corresponds to that of standard solution as obtained in Assay
Melting Point Limit : 180 0 C to 195 0 C
Related Substances
1) Any Single Impurity
2) Total Impurities 		Limit : Max. 3.0%
Max. 0.5%
Loss on drying Limit: Max. 1.00% w/w
Assay
(On Dried Basis)
(By H.P.L.C.)		 Limit: Min. 95%




Phthaloyl Amlodipine
Test Phthaloyl Amlodipine
Appearance Pale yellow crystalline Powder
Solubility Soluble in Ethyl Acetate, chloroform
Melting Point Soluble in Ethyl Acetate, chloroform
Loss on drying NMT 1.0 %
Assay NLT 99.0 %






Alendronic Acid | 4 Amino Butyric Acid | Ibandronic Acid | 3-(N-methylpenthylamino) propionic acid HCl | 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
 PRODUCT SPECIFICATIONS
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