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CERTIFICATE OF ANALYSIS
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Name of product |
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Lot No. | 1309003 | Report No. | 13003 |
Quantity | 1000kg | Test date | ?? Sep.03,2013 |
Manufacture date | ?? Sep.02,2013 | Expiry date | ?Sep.01,2017 |
Quality standard | BP2002/USP28 | ||
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Test | Standards | Results | |
Characteristics | A yellowish or orange, crystalline powder. Practically insoluble in water and in most organic solvents. It dissolves in dilute acids and in alkaline solutions. | A yellowish crystalline powder. Practically insoluble in water and in most organic solvents. It dissolves in dilute acids and in alkaline solutions. | |
Identification | A: Specific optical rotation | +18 to +22 (anhydrous substance) | 19.2 |
B:HPLC chromatograms | Complies | Complies | |
C:TLC Identification | Complies | Complies | |
Related substance | Impurity Anot more than 0.5% | 0.4 | |
Impurity D not more than 0.6% | ? ? ? ? ? ? ? ? ? ? ? ?0.5 | ||
any other impurity not more than 0.5% | ? ? ? ? ? ? ? ? ? ? ? ?0.4 | ||
Total of other impurity not more than 1.0% | 0.8 | ||
UV absorption ratio | A256/A365:2.80-3.0 | 2.90 | |
Free amines | NMT 1/6 | 1/7 | |
Organic volatile impurities | Conforms | Conforms | |
Chromatographic purity | Not more than2.0% | ? ? ? ? ? ? ? ? ? ?1 .74% | |
Sulphated ash | Not more than 0.2% | 0.13% | |
Lead | 2ppm Max | ? ? ? ? ? ? ? Conforms | |
Total plate count? | ???????? 1000CFU/g Max | ? ? ? ? ? ? ?25CFU/g | |
Particle size | ???????? 100% pass 100mesh | ? ? ? ? ? ? ?Conforms | |
Salmonella | ????????????? Absent | ? ? ? ? ? ? ?Conforms | |
E Coli | Absent | ? ? ? ? ? ? ?Conforms | |
Water | 5.0 %- 8.5 % | 7.5% | |
Assay(HPLC) | 97.0-102.0%(anhydrous basis) | 97.2% | |
Conclusion :?????????????? Complies with BP2002/USP28 | |||
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Biddle Sawyer Fortune Chem ( Asian Sales Division of Biddle Sawyer New York ) sells proven quality ofFolic Acid on a regular basis.
Contact Point :
Mr. S. M. Kang, CEO
Mr.Jingu Kang, Manager
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Tel : 82-(0)51-701-9121
Fax : 82-(0)51-701-9125
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Please click “ CONTACT SUPPLIER “ above so that we may reply therein or inform you the person in charge name and his/her email address and company website.
All Payment including shipping documents procedure and strict quality management to be done by Biddle Sawyer New York in cooperation with very well-trained ( including TBM : Time Based Management ) Biddle Sawyer’s overseas offices and affiliations
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Custom Manufacturing and Development Capabilities
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R&D at 6 labs (affiliate or contract)
~350 Chemists at 6 facilities in USA, China, Korea, Taiwan, India and Finland
~40 PhD's, ~120 M.S.; External consultants welcomed
~400 combined hoods
Up to 100L vessels in labs
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Development Services
Tech Transfer
Process R&D
Analytical Development
Custom Synthesis; FTE
Kilo lab production
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Analytical Equipment
LC's GC's LC/MS GC/MS NMR IR UV KF
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Production Capabilities
Production at 6 plants (affiliate or contract)
>150 vessels at 6 facilities in USA, China, Korea, Taiwan and Finland
>2000m3 capacity
Vessels from 300L to 10,000L
Temps from -80 to 350C
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Production Services
Tech Transfer
Scale Up
Optimization
Non-GMP and GMP (FDA inspected)
Pilot to large commercial scale
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