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


ALENDRONIC ACID
CAS No. 66376-36-1
CAS NAME (4-Amino-1-hydroxybutylidene)bisphosphonic acid
ADDITIONAL NAME ?-hydroxy-?-aminobutylidenediphosphonic acid
MOLECULAR WT. 249.10
CHEMICAL COMPOSITION C H NO P 4 13 7 2
TEST SPECIFICATION
DESCRIPTION FINE WHITE POWDER
SOLUBILITY INSOLUBLE IN WATER
IDENTIFICATION A. I. R. TEST
CHROMATOGRAPH BY TLC ABSENCE OF SECONDARY SUBSTANCE
HEAVY METALS LIMIT : Max .20PPM
LOSS OF DRYING (By Kf) 1% W/W
4-AMINOBUTANOIC ACID (by TLC) LIMIT MAX.0.1%
PHOSPHATE LIMIT MAX.0.5%
PHOSPHITE LIMIT MAX.0.5%
RESIDUAL SOLVENTS LIMIT MAX. 10 PPM
ASSAY (TITRATION) LIMIT: 98% to 102%




AMINO BUTYRIC ACID OR 4 - AMINOBUTANOIC 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. 1PPM
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
DESCRIPTION LIGHT YELLOW CRYSTALS
MELTING POINT LIMIT: 93 C TO 96 c
SOLUBILITY PASSES IN ETHANOL
TLC PASSES IN SINGLE SPOT




BENZILLIC ACID
SYNONYM HYDROXY PHENYLBENZENE ACETIC OR DIPHENYLALYCOLIC ACID
CAS NO 76- 98- 7
MOLECULAR FORMULA C 14 H 12 O3
MOLECULAR WEIGHT 228.24
DESCRIPTION ALMOST WHITE CRYSTALLINE POWDER ODOURLESS TASTE BITTER
MELTING POINT LIMIT 148 c TO 150 c
SOLUBILITY SLIGHTLY SOLUBLE IN COLD WATER, HIGHLY SOLUBLE IN HOT WATER, ALCOHOL, ETHER
ASSAY LIMIT: MIN. 98.0%
LOSS OF DRYING LIMIT: MAX. 1.0%
SULPHATED ASH LIMIT: MAX. 0.1%
CHLORIDE (Cl) LIMIT: MAX.0.01%
SULPHATE (SO4) LIMIT: MAX 0.02%




BENZOIN
CHEMICALS NAME ACETOPHENONE, 2-HYDROXY-2-PHENYL OR ETHANONE, 2-HYDROXY-1, 2-DIPHENYL OR A-HYDROXY-A-PHENYLACETOPHENONE
CAS NO. 119-53-9
FORMULA C14H1202
DESCRIPTION CREAMISH CRYSTALLINE
SOLUBILITY COMPLIES (IN ACETONE)
TLC COMPLIES (SINGLE SPOT)
MELTING POINT LIMIT 132 c TO 136 c




CAPROIC ANHYDRIDE
SYNONYM HEXADECANOIC ANHYDRIDE
CHEMICALS FORMULA CH3 (CH2)4CO=O=CO(CH2)CH3
ASSAY 97% MIN
ACID VALUE AS FREE CAPRPOC ACID 1.50%
IODINE VALUE 1%
COLOUR COLURLESS TO PALE YELLOW
PACKING 50 KGS & 180 KGS HDPE CARBOY / LINER




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




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
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)
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 (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
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-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 Range Limit : 600 C to 63 0 C
Moisture Limit: Max. 0.5%
Assay (By G.C.) Limit: Min. 98%




RISEDRONIC ACID
CAS No: 105462-24-6
Chemical Name [1-Hydroxy-2-(3-pyridinyl)ethylidene]bisphosphonic acid
Molecular formula C1H11NO7P2
Molecular Weight 283.11
Test Specification
Description White to off white Crystalline powder
Identification 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 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