Lineas de producción

D(-) Alpha Phenylglycine

Packing material:
25 kg cardboard box

Handling & storage:
Prevent rough handling and store in a dry area, max. storage temperature 20 – 25°C. Avoid exposure to direct sunlight and take precautionary measures against static discharges.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 3 years. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the manufacturing of Ampicillin, Cephalexin and Cephaclor.

Characteristics
Appearance: Crystalline
Colour: White to off white

Identification
(F.T.I.R.): Positive

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Assay
(Potentiometric Titration): Not less than 99,.0 % w/w

Specific Rotation [ ]d20
(C= 1%, 1N HCl):-161,0° to 155,0°

Water Content
(Karl Fisher): Not more than 0,20 % w/w

Iron Content (ppm)
(Colorimetric Assay): Not more than 10 mg/kg


D(-) Alpha Phenylglycine Dane Salt (Ethyl Potassium) Danfenil®

Packing material:
Big-bags of various Kg sizes/25 kg cardboard box

Handling & storage:
Prevent rough handling and store in a dry area, max. storage temperature 20 – 25°C. Avoid exposure to direct sunlight and take precautionary measures against static discharges.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 9 months. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the manufacturing of Ampicillin, Cephalexin and Cephaclor.

Characteristics
Appearance: Crystalline
Colour: White to off white

Identification
(F.T.I.R.): Positive

prod_1

Assay
(Potentiometric Titration): Not less than 99,.0 % w/w

Specific Rotation [ ]d20
(C= 4%, 1N HCl):
-82,0° to 78,0°

Water Content
(Karl Fisher): Not more than 0,50 % w/w

Iron Content (ppm)
(Colorimetric Assay): Not more than 5 mg/kg


D(-) Phenylglycine Amide

Packing material:
IBC’s (intermediate Bulk containers): Big-bags of various sizes.

Handling & storage:
Ventilation provided with dust filter required.Prevent forming of dust clouds.Keep container tightly closed and dry.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 18 months. After this period re-testing will indicate its suitability for use.

Application:
Side Chain used in the production of Cephalexine

Characteristics
Appearance: Crystalline
Colour: White to off-white crystalline powder

HPLC (Stereoisomers)
Enantiomeric excess:Not less than 99,0 %

 

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Titration (AgNO3, 0.01M)
Chloride:Not more than 5.000 ppm

Absorbance (420 nm)
C=10, 1M H2S04
Not more than 0,10 AU

HPLC (Assay)
L(+)-Phenylglycine:
Not more than 0,3 % m/m
Others total:
Not more than 0,5 % m/m

 


D(-) Alpha Parahydroxy Phenylglycine

Packing material:
50 kg drum / 25 kg cardboard box.

Handling & storage:
Prevent rough handling and store in a dry area, max. storage temperature 20 – 25°C. Avoid exposure to direct sunlight and take precautionary measures against static discharges.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 3 years. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the manufacturing of Amoxicillin & Cephadroxil.

Characteristics
Appearance: Crystalline
Colour: White to off-white powder

Identification:
(F.T.I.R.): Positive

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Assay:
(Potentiometric Titration):
Not less than 99,0 % (w/w)

Specific Rotation [ ]d20:
(C= 1%, 1N HCl): -161,0° to -156,0°

Water Content:
(Karl Fisher): Not more than 0,20% (w/w)

Iron Content (ppm):
(Colorimetric Assay):Not more than 5 ppm.

 


D(-) Alpha Parahydroxy Phenylglycine Dane Salt (Methyl Potassium) Danoxi ®

Packing material:
50 kg drum / 25 kg cardboard box / Big Bag or big-bags of different kg sizes

Handling & storage:
Prevent rough handling and store in a dry area, max. storage temperature 20 – 25°C. Avoid exposure to direct sunlight and take precautionary measure against static discharges.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 1 year. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the production of Amoxicillin & Cephadroxil.
Characteristics
Appearance: Crystalline powder
Colour: White to off white

Identification:
(F.T.I.R.): Positive

Assay:
(Potentiometric Titration):
Not less than 99,0 % (w/w)

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Specific Rotation [ ]d20:
(C= 4%, 1N HCl):-90,0¼ to -85,0°

Water Content:
(Karl Fisher):Not more than 0,50% (w/w)

Iron Content (ppm): (Colorimetric Assay):Not more than 5 mg/kg.

D(-) Alpha Parahydroxy Phenylglycine
(Spectrophotometric Assay):
Not more than 0,50 % (w/w)


D(-) Alpha Parahydroxy Phenylglycine

Packing material:
50 kg drum / 25 kg cardboard box.

Handling & storage:
Prevent rough handling and store in a dry area, max. storage temperature 20 – 25°C. Avoid exposure to direct sunlight and take precautionary measures against static discharges.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 3 years. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the manufacturing of Amoxicillin & Cephadroxil.

Characteristics
Appearance: Crystalline
Colour: White to off-white powder

Identification:
(F.T.I.R.): Positive

prod_1

Assay:
(Potentiometric Titration):
Not less than 99,0 % (w/w)

Specific Rotation [ ]d20:
(C= 1%, 1N HCl): -161,0° to -156,0°

Water Content:
(Karl Fisher): Not more than 0,20% (w/w)

Iron Content (ppm):
(Colorimetric Assay):Not more than 5 ppm.

 


D(-) Alpha 2,5 Dihidrophenylglycine Dane Salt (Methyl Sodium) Danhidro ®

Packing material:
Int. polyethylene bag-text. Aluminium bag/ 15 kg/cardboard box

Handling & storage:
Always mantain integrity of packing material avoid breaking it. Preferably store at max. 5º C; low temperature keeps Product stability; temperature above 25° C lead to increase stability. Handle with a closed system a.f.a.p.; product sensitive to air and light.

Re-evaluation period:
When stored under the condition described above, the re-evaluation period is 6 months. After this period re-testing will indicate its suitability for use.

Application:
Side chain used in the production of Amoxicillin & Cephadroxil.

Appearance
Lump free white to almost white powder

Identification:
HPLC: Retention time conforms standard
Specific rotation:
Meets specification

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Titration (Water content)
(Karl Fischer) Not less than 0,50 % (w/w)

Absorbance
(C=10% (w/v) in H2O at 420 nm) Not more than 0,200 u.a.

Titration (HCLO4 0,1 M)
Not less that 99,0% (w/w)

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