Risperidone CAS 106266-06-2 Assay 98.0~102.0%

Short Description:

Chemical Name: Risperidone 

CAS: 106266-06-2

Assay: 98.0~102.0% (Calculated on the Dried Basis)

Appearance: White to Off-White Powder 

Contact: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com


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106266-06-2 - Description:

Shanghai Ruifu Chemical Co., Ltd. is the leading manufacturer of Risperidone (CAS: 106266-06-2) with high quality. Ruifu Chemical can provide worldwide delivery, competitive price, excellent service, small and bulk quantities available. Purchase Risperidone, Please contact: alvin@ruifuchem.com

Intermediates of Risperidone:

106266-06-2 - Chemical Properties:

Chemical Name Risperidone  
Synonyms 3-[2-[4-(6-Fluoro-1,2-Benzisoxazol-3-yl)-1-Piperidinyl]ethyl]-6,7,8,9-Tetrahydro-2-Methyl-4H-Pyrido[1,2-a]pyrimidin-4-one; Risperdal; Risperidal; Risperdal Consta; Rispolept; Risperin; Rispolin; Sequinan; Risperdal M-Tab
Stock Status In Stock, Commercial Production  
CAS Number 106266-06-2
Molecular Formula C23H27FN4O2
Molecular Weight 410.49 g/mol
Melting Point 170.0 to 174.0℃ 
Density 1.38±0.10 g/cm3 
Hazard Class 6.1; Poison
COA & MSDS Available
Origin Shanghai, China
Brand Ruifu Chemical

106266-06-2 - Specifications:

Items Specifications  Results
Appearance White to Off-White Powder  Complies             
Identification A Infrared Absorption Complies  
Identification B Retention Time: Corresponds to Reference Substance   Complies 
Loss on Drying <0.50% 0.12%
Residue on Ignition <0.10% 0.07%
Heavy Metals <0.001% <0.001%
Related Compounds
E-Oxime <0.20% <0.20%
Z-Oxime <0.20% <0.20%
9-Hydroxyrisperidone <0.20% <0.20%
5-Fluororisperidone <0.20% <0.20%
6-Methylrisperidone <0.20% <0.20%
Any Unknown Impurity <0.10% <0.10%
Total Impurities <0.30% <0.30%
Assay   98.0~102.0% (Calculated on the Dried Basis) 100.52%
Conclusion The product has been tested and complies with the USP 35 Standard 

Package/Storage/Shipping:

Package: Bottle, 1kg/Tin, 5kg/Tin, 25kg/Cardboard Drum, or according to customer's requirement.
Storage Condition: Keep the container tightly closed and store in a cool, dry (2~8℃) and well-ventilated warehouse away from incompatible substances. Protect from light and moisture.
Shipping: Deliver to worldwide by air, by FedEx / DHL Express. Provide fast and reliable delivery. 

106266-06-2 - USP 35 Standard :

Risperidone
C23H27FN4O2 410.48
4H-Pyrido[1,2-a]pyrimidin-4-one, 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-.
3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one [106266-06-2].
» Risperidone contains not less than 98.0 percent and not more than 102.0 percent of C23H27FN4O2, calculated on the dried basis.
Packaging and storage- Preserve in well-closed containers. Store at room temperature.
USP Reference standards <11>-
USP Risperidone RS
3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidino]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one 410.48 CAS-106266-06-2
USP Risperidone System Suitability Mixture RS
Contains risperidone and about 0.2% of each of the following:
Z-Oxime-3-[2-[4-[(Z)-(2,4-difluorophenyl)(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
9-Hydroxyrisperidone-(6RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
6-Methylrisperidone-(6RS)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one.
[Note-This mixture contains risperidone, Z-oxime, 9-hydroxyrisperidone, and 6-methylrisperidone.]
Identification-
A: Infrared Absorption <197K>.
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.
Loss on drying <731>- Dry in vacuum at 80 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition <281>: not more than 0.1%, a 2.0-g test specimen being used.
Heavy metals, Method II <231>: 0.001%.
Related compounds-
Buffer solution, Solution A, Solution B, Mobile phase, Diluent, System suitability solution, and Chromatographic system-Prepare as directed in the Assay.
Standard solution-Use the Standard preparation, prepared as directed in the Assay.
Test solution-Use the Assay preparation.
Procedure-Inject equal volumes (about 10 µL) of the Standard solution and the Test solution into the chromatograph, and record the chromatogram. Identify the impurities using the relative retention times given in Table 1, and measure the peak responses. Calculate the percentage of each risperidone related compound in the portion of Risperidone taken by the formula:
100(CS /CU)(rU / rS)(1/F)
in which CS and CU are the concentrations, in mg per mL, of risperidone in the Standard solution and the Test solution respectively; rU is the peak area of each impurity obtained from the Test solution; rS is the peak area of risperidone obtained from the Standard solution; and F is the relative response factor for each impurity relative to risperidone. In addition to not exceeding the limits in Table 1, not more than 0.10% of any unknown impurity (use F value of 1.0) is found and not more than 0.30% of the total impurities is found. Disregard the impurity peaks that are less than 0.05%.
Table 1
Related Compound Relative Retention Time (RRT) Relative Response Factor (F) Limit (%)
E-oxime1 0.60 1.0 NMT 0.20
Z-oxime2 0.67 0.63 NMT 0.20
9-hydroxyrisperidone3 0.76 0.92 NMT 0.20
5-fluororisperidone4 0.94 1.0 NMT 0.20
Risperidone 1.0 1.0 -
6-methylrisperidone5 1.2 0.95 NMT 0.20
1 3-[2-[4-[(E)-(2,4-Difluorophenyl)(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
2 3-[2-[4-[(Z)-(2,4-Difluorophenyl)(hydroxyimino)methyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
3 (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
4 3-[2-[4-(5-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
5 (6RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6-dimethyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
Assay-
Buffer solution- Dissolve 15.4 g of ammonium acetate in 1 L of water. Adjust with 10% acetic acid to a pH of 6.5, and mix.
Solution A-Mix 100 mL of Buffer solution with 150 mL of methanol in a 1000-mL volumetric flask, and dilute with water to volume.
Solution B- Mix 100 mL of Buffer solution with 850 mL of methanol in a 1000-mL volumetric flask, and dilute with water to volume.
Mobile phase-Use variable mixtures of Solution A and Solution B as directed for Chromatographic system. Make adjustments if necessary (see System Suitability under Chromatography 621).
Diluent-Mix 100 mL of Buffer solution with 900 mL of water and 1000 mL of methanol.
System suitability solution-Prepare a 1 mg per mL solution of USP Risperidone System Suitability Mixture RS in Diluent.
Standard preparation-Dissolve an accurately weighed quantity of USP Risperidone RS in Diluent, and dilute quantitatively, and stepwise if necessary, with Diluent to obtain a solution having a known concentration of about 1.0 mg per mL.
Assay preparation-Dissolve an accurately weighed quantity of Risperidone in Diluent, and dilute quantitatively, and stepwise if necessary, with Diluent to obtain a solution having a concentration of about 1.0 mg per mL.
Chromatographic system (see Chromatography <621>)- The liquid chromatograph is equipped with a 275-nm detector and a 4.6-mm × 10-cm column that contains 3-µm packing L1. The flow rate is about 1.5 mL per minute. The column temperature is maintained at 35. The chromatograph is programmed as follows.
Time (minutes) Solution A (%) Solution B (%) Elution
0–1 70 30 isocratic
1–20 70®5 30®95 linear gradient
20–25 5 95 isocratic
25–27 5®70 95®30 linear gradient
27–35 70 30 re-equilbrationInject the System suitability solution. Record the peak responses as directed for Procedure, and identify the peaks due to Z-oxime, 9-hydroxyrisperidone, 6-methylrisperidone, and risperidone using the relative retention times (RRT) from Table 1; the resolution, R, between Z-oxime and 9-hydroxyrisperidone is not less than 2.8; the tailing factor for risperidone is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0% for the risperidone peak.
Procedure- Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, and measure the responses for the risperidone peak. Calculate the quantity, in percent of C23H27FN4O2, in the portion of Risperidone taken by the formula:
100(CS /CU)(rU / rS)
in which CS and CU are the concentrations, in mg per mL, of risperidone in the Standard preparation and the Assay preparation, respectively; and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively. 

Advantages:

Sufficient Capacity: Sufficient facilities and technicians

Professional Service: One stop purchasing service

OEM Package: Custom package and label available

Fast Delivery: If within stock, three days delivery guaranteed

Stable Supply: Maintain reasonable stock    

Technical Support: Technology solution available

Custom Synthesis Service: Ranged from grams to kilos

High Quality: Established a complete quality assurance system

FAQ:

How to Purchase? Please contact Dr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com 

15 Years Experience? We have more than 15 years of experience in the manufacture and export of a wide range of high quality pharmaceutical intermediates or fine chemicals.

Main Markets? Sell to domestic market, North America, Europe, India, Korea, Japanese, Australia, etc.

Advantages? Superior quality, affordable price, professional services and technical support, fast delivery.

Quality AssuranceStrict quality control system. Professional equipment for analysis include NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, K.F, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc.

SamplesMost products provide free samples for quality evaluation, shipping cost should be paid by customers.

Factory AuditFactory audit welcome. Please make an appointment in advance.

MOQ? No MOQ. Small order is acceptable.

Delivery Time? If within stock, three days delivery guaranteed.

TransportationBy Express (FedEx, DHL), by Air, by Sea.

Documents? After sales service: COA, MOA, ROS, MSDS, etc. can be provided.

Custom SynthesisCan provide custom synthesis services to best fit your research needs.

Payment TermsProforma invoice will be sent first after confirmation of order, enclosed our bank information. Payment by T/T (Telex Transfer), PayPal, Western Union, etc. 

106266-06-2 - Risk and Safety:

Risk Codes R25 - Toxic if swallowed
R23/24/25 - Toxic by inhalation, in contact with skin and if swallowed.
R11 - Highly Flammable
Safety Description S28 - After contact with skin, wash immediately with plenty of soap-suds.
S36 - Wear suitable protective clothing.
S45 - In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)
S36/37 - Wear suitable protective clothing and gloves.
S16 - Keep away from sources of ignition.
UN IDs 3249
WGK Germany 3
RTECS UV1164800
HS Code 2934999099
Hazard Class 6.1(a)
Packing Group II

106266-06-2 - Application:

Risperidone (CAS: 106266-06-2) has antagonism effect on 5HT2 receptors and D2 receptors. Risperidone is used for acute and chronic schizophrenia. Antipsychotic drugs. Risperidone is used for the treatment of acute and chronic schizophrenia and other various psychotic state obvious positive symptoms (such as hallucinations, illusions, thought disorder, hostility, suspicion) and significant negative symptoms (such as unresponsiveness, emotional apathy and social apathy, of few words). Also it can alleviate affective symptoms associated with schizophrenia (such as: depression, guilt, anxiety). For patients whom Risperidone is effective to for acute treatment ,in the maintenance phase of treatment, the Risperidone can continue to play its clinical efficacy. Risperidone, therefore, has therapeutic action on both positive and negative symptoms of schizophrenia and produces significantly fewer side effects especially extrapyramidal symptoms compared with commonly used pure D2 antagonist antipsychotics. It also has potential for management of alcohol withdrawal and cocaine addiction. 

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