Cytarabine (Ara-C) CAS 147-94-4 Assay 98.0%~102.0% Factory High Quality

Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer of Cytarabine (Ara-C) (CAS: 147-94-4) with high quality. Ruifu Chemical can provide worldwide delivery, competitive price, excellent service, small and bulk quantities available. Purchase Cytarabine, Please contact: alvin@ruifuchem.com 

Package: Bottle, Aluminium foil bag, 25kg/Cardboard Drum, or according to customer's requirement.
Storage Condition: Keep the container tightly closed and store in a cool, dry and well-ventilated warehouse away from incompatible substances. Keep away from sunshine; avoid fire and heat sources; avoid moisture.
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Cytarabine
C9H13N3O5 243.22
2(1H)-Pyrimidinone, 4-amino-1--d-arabinofuranosyl-.
1--d-Arabinofuranosylcytosine [147-94-4].
» Cytarabine contains not less than 98.0 percent and not more than 102.0 percent of C9H13N3O5, calculated on the dried basis.
Packaging and storage- Preserve in well-closed, light-resistant containers.
Labeling- Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards <11>-
USP Cytarabine RS
USP Endotoxin RS
USP Uracil Arabinoside RS
Identification-
A: Infrared Absorption <197M>: previously dried at a pressure of not more than 5 mm of mercury at 60 for 3 hours.
B: The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Specific rotation <781S>: between +154 and +160.
Test solution: 10 mg per mL, in water.
Loss on drying <731>- Dry it in vacuum at a pressure not exceeding 5 mm of mercury at 60 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition <281>: not more than 0.5%.
Heavy metals, Method II <231>: 0.001%.
Chromatographic purity-
Phosphate buffer- Prepare a solution containing 0.01 M monobasic sodium phosphate and 0.01 M dibasic sodium phosphate in a suitable container. Adjust with 0.1 M sodium hydroxide or 0.1 M phosphoric acid to a pH of 7.0.
Solution A- Prepare a filtered and degassed mixture of Phosphate buffer and methanol (49:1). Make adjustments if necessary (see System Suitability under Chromatography <621>). Prepare this solution fresh daily.
Solution B- Prepare a filtered and degassed mixture of Phosphate buffer and methanol (7:3). Make adjustments if necessary (see System Suitability under Chromatography <621>). Prepare this solution fresh daily.
Mobile phase- Use variable mixtures of Solution A and Solution B as directed under Chromatographic system.
System suitability solution- Dissolve suitable quantities of uridine, USP Uracil Arabinoside RS, and USP Cytarabine RS in water to obtain a solution containing about 0.02, 0.02, and 5.0 mg per mL, respectively.
Standard solution- Dissolve an accurately weighed quantity of USP Cytarabine RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about 4 µg per mL.
Test solution- Transfer about 25 mg of Cytarabine, accurately weighed, to a 5.0-mL volumetric flask, dissolve in and dilute with water to volume, and mix. [note-Prepare this solution fresh daily.]
Chromatographic system (see Chromatography <621>)-The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 1 mL per minute. The chromatograph is programmed to provide variable mixtures of Solution A and Solution B, the percentage of Solution B being 0% at the time of injection. This composition is held for 10 minutes. Solution B is then linearly increased to 100% over a period of 10 minutes. After maintaining this composition for 5 minutes, the percentage of Solution B is then linearly decreased to 0% over a period of 5 minutes. This composition is maintained for 20 minutes to equilibrate the system. Chromatograph the System suitability solution, and record the peak responses as directed under Procedure: the relative retention times are about 0.55 for uracil, 1.14 for uridine, 1.62 for uracil arabinoside, and 1.0 for cytarabine; and the resolution, R, between cytarabine and uridine is not less than 1.25. Chromatograph the Standard solution, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 3.0%.
Procedure- Inject equal volumes (about 20 µL) of the Standard solution and the Test solution into the chromatograph, record the chromatograms, and measure the peak responses. Calculate the percentage of uracil arabinoside in the portion of Cytarabine taken by the formula:
500(C / W)(ri / 1.34rS)
in which C is the concentration, in mg per mL, of USP Cytarabine RS in the Standard solution; W is the weight, in mg, of the specimen, 1.34 is the relative response factor for uracil arabinoside; ri is the peak response of uracil arabinoside in the Test solution; and rS is the peak response of USP Cytarabine RS in the Standard solution: not more than 0.30% is found.
Calculate the percentage of all other impurities in the portion of Cytarabine taken by the formula:
500(C / W)(ri / FrS)
in which C is the concentration, in mg per mL, of USP Cytarabine RS in the Standard solution; W is the weight, in mg, of the specimen; ri is the peak response of each impurity in the Test solution; rS is the peak response of USP Cytarabine RS in the Standard solution; and F, the relative response factor, equals 2.5 for the uracil peak, with a relative retention time of 0.55, 1.5 for peaks with relative retention times of 0.38, 0.43, and 1.14, and 1.0 for all other peaks. Not more than 0.10% of any individual impurity is found, and not more than 0.30% of total impurities is found (including uracil arabinoside).
Other requirements- Where the label states that Cytarabine is sterile, it meets the requirements for Sterility Tests 71 and for Bacterial endotoxins under Cytarabine for Injection. Where the label states that Cytarabine must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements for Bacterial endotoxins under Cytarabine for Injection.
Assay-
Phosphate buffer- Dissolve 0.73 g of monobasic sodium phosphate and 1.4 g of dibasic sodium phosphate in 1 L of water, mix, and filter.
Mobile phase- Prepare a filtered and degassed mixture of Phosphate buffer and methanol (95:5). Make adjustments if necessary (see System Suitability under Chromatography <621>).
Standard preparation- Dissolve an accurately weighed quantity of USP Cytarabine RS in water, and dilute quantitatively, and stepwise if necessary, with water to obtain a solution having a known concentration of about 0.1 mg per mL.
Resolution solution- Dissolve an accurately weighed quantity of USP Uracil Arabinoside RS in Standard preparation, and dilute quantitatively, and stepwise if necessary, with Standard preparation to obtain a solution having a known concentration of about 0.1 mg per mL.
Assay preparation- Transfer about 10 mg of Cytarabine, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with water to volume, and mix.
Chromatographic system (see Chromatography <621>)-The liquid chromatograph is equipped with a 254-nm detector and a 4.6-mm × 25-cm column that contains packing L1. The flow rate is about 1.0 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: the relative retention times are about 1.0 for cytarabine and 1.3 for uracil arabinoside; and the resolution, R, between cytarabine and uracil arabinoside is not less than 2.5. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative standard deviation for replicate injections is not more than 2.0%. [note-After chromatography has been completed, flush the column with a mixture of water and methanol (7:3).]
Procedure- Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C9H13N3O5 in the portion of Cytarabine taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Cytarabine RS in the Standard preparation; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.

Risk Codes R43 - May cause sensitization by skin contact
R63 - Possible risk of harm to the unborn child
R36/37/38 - Irritating to eyes, respiratory system and skin.
R20/21/22 - Harmful by inhalation, in contact with skin and if swallowed.
Safety Description S36/37 - Wear suitable protective clothing and gloves.
S37/39 - Wear suitable gloves and eye/face protection
S36 - Wear suitable protective clothing.
S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
WGK Germany 3
RTECS HA5425000
FLUKA BRAND F CODES 10-23
HS Code 2934999099

Cytarabine (CAS: 147-94-4) is a kind of purine nucleoside-class antiviral chemical synthesis that initially extracted from the medium of streptomyces, and then produced from chemical synthesis. It is a white crystalline powder and is very slightly soluble in water. Its monophosphate ester is easily soluble in water. It has inhibitory effect on various kinds of DNA virus such as Herpes simplex virus HSV1 and HSV2, hepatitis B virus, varicella-zoster virus and cytomegalovirus. Cytarabine (CAS: 147-94-4), a chemotherapy agent used mainly in the treatment of cancers of white blood cells such as acute myeloid leukemia (AML) and non-Hodgkin lymphoma . Cytarabine is a cytosine analogue and antineoplastic agent used largely in the therapy of acute leukemia. Cytarabine is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, but has only rarely been implicated in cases of clinically apparent acute liver injury with jaundice.