Pramipexole Dihydrochloride Monohydrate CAS 191217-81-9 Assay 98.0~102.0%
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| Chemical Name | Pramipexole Dihydrochloride Monohydrate |
| Synonyms | Pramipexole DiHCL Monohydrate; Pramipexole 2HCl Monohydrate; (S)-2-Amino-4,5,6,7-Tetrahydro-6-(Propylamino)benzothiazole Dihydrochloride Monohydrate |
| Stock Status | In Stock, Commercial Production |
| CAS Number | 191217-81-9 |
| Related CAS | 104632-25-9 & 104632-26-0 |
| Molecular Formula | C10H17N3S·2HCl·H2O |
| Molecular Weight | 302.26 g/mol |
| Melting Point | 290℃(dec.) |
| Specific Rotation [a]20/D | -65.0° to -71.0° (C=1 in MeOH) (Calculated on the Anhydrous Basis) |
| Water Solubility | Soluble in Water |
| Solubility | Soluble in Methanol. Very Slightly Ethanol. Insoluble in Dichloromethane |
| COA & MSDS | Available |
| Origin | Shanghai, China |
| Brand | Ruifu Chemical |
| Items | Specifications | Results |
| Appearance | White to Off-White Crystalline Powder | Complies |
| Assay | 98.0~102.0% (Calcd. on the Anhydrous Basis) | 99.8% |
| Water by Karl Fischer | 4.5~6.5% | 4.9% |
| Residue on Ignition | ≤0.10% | <0.10% |
| Heavy Metals (Pb) | ≤10ppm | <10ppm |
| Related Substances | ||
| Pramipexole Propionamidea | ≤0.15% | Complies |
| Pramipexole Related Compound A | ≤0.15% | Complies |
| N-Propylpramipexole | ≤0.15% | Complies |
| Pramipexole Dimer | ≤0.15% | Complies |
| Any Other Unidentified Individual Impurity | ≤0.10% | Complies |
| Enantiomeric Purity | ≤1.00% of Pramipexole Related Compound D | Complies |
| Palladium | ≤5ppm | <5ppm |
| Infrared Spectrum | Consistent with Structure | Complies |
| Conclusion | Has been tested and complies with the given specifications | |
Package: Fluorinated 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 (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.
C10H17N3S·2HCl·H2O 302.26
(S)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate [191217-81-9].
DEFINITION
Pramipexole Dihydrochloride contains NLT 98.0% and NMT 102.0% of C10H19Cl2N3S, calculated on the anhydrous basis.
IDENTIFICATION
• A. Infrared Absorption <197A> or <197M>
Wave number range: <197A>, 3800 cm-1 to 650 cm-1; <197M>, 4000 cm-1 to 600 cm-1
• B. The retention time of the major peak in the Sample solution corresponds to that of pramipexole (S-enantiomer) in the System suitability solution in the test for Enantiomeric Purity.
• C. Identification Tests-General, Chloride <191>
Sample: 1 mg/mL of Pramipexole Dihydrochloride in water
Acceptance criteria: Meets the requirements of the silver nitrate precipitate test
ASSAY
• Procedure
Solution A: Dissolve 9.1 g of potassium dihydrogen phosphate and 5.0 g of sodium 1-octanesulfonate monohydrate in 1 L of water. Adjust with phosphoric acid to a pH of 3.0.
Solution B: Acetonitrile and Solution A (1:1)
Diluent: Acetonitrile and Solution A (1:4)
Mobile phase: See the gradient table below.
Time (min) Solution A (%) Solution B (%)
0 60 40
15 20 80
15.1 60 40
20 60 40
System suitability solution: 1.5 mg/mL of USP Pramipexole Dihydrochloride RS and 0.8 mg/mL of USP Pramipexole Related Compound A RS in Diluent
Standard solution: 1.5 mg/mL of USP Pramipexole Dihydrochloride RS in Diluent
Sample solution: 1.5 mg/mL of Pramipexole Dihydrochloride in Diluent
Chromatographic system
(See Chromatography <621>, System Suitability.)
Mode: LC
Detector: UV 264 nm
Column: 4.6-mm × 15-cm; 5-µm packing L1
Column temperature: 40 ± 5
Flow rate: 1.5 mL/min
Injection size: 5 µL
System suitability
Samples: System suitability solution and Standard solution [Note-The relative retention times for pramipexole related compound A and pramipexole are about 0.7 and 1.0, respectively. ]
Suitability requirements
Resolution: NLT 6.0 between pramipexole related compound A and pramipexole, System suitability solution
Tailing factor: NMT 2.0 for pramipexole, System suitability solution
Relative standard deviation: NMT 1.0%, Standard solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of C10H19Cl2N3S in the portion of Pramipexole Dihydrochloride taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = peak response from the Sample solution
rS = peak response from the Standard solution
CS = concentration of USP Pramipexole Dihydrochloride RS in the Standard solution (mg/mL)
CU = concentration of the Sample solution (mg/mL)
Mr1 = molecular weight of pramipexole dihydrochloride, 284.26
Mr2 = molecular weight of pramipexole dihydrochloride monohydrate, 302.26
Acceptance criteria: 98.0%-102.0% on the anhydrous basis
IMPURITIES
Inorganic Impurities
• Residue on Ignition <281>: NMT 0.10%
• Heavy Metals, Method I <231>
Standard solution: Standard Lead Solution, 10 ppm
Sample solution: Ash 2 g of Pramipexole Dihydrochloride until an almost dry, carbonized mass is obtained. Cool the residue, add 2.0 mL of concentrated nitric acid and 5 drops of concentrated sulfuric acid, and carefully allow the fumes to evolve. Ignite at 500-600 until the carbon is completely burned off. Cool the residue, add 4 mL of 6 M hydrochloric acid, cover the crucible, and digest on a boiling water bath for 15 min. Evaporate to dryness. Add one drop of concentrated hydrochloric acid and 10 mL of hot water, and digest for a further 2 min on the boiling water bath. Add 6 M ammonia solution dropwise until the solution is weakly alkaline, and adjust with 1 M acetic acid to a pH of 3.0-4.0. Filter the solution into a 25-mL volumetric flask, and dilute with water to 25 mL by washing the crucible and the filter.
Acceptance criteria: NMT 10 ppm
Organic Impurities
• Procedure
Solution A, Solution B, Diluent, Mobile phase, and Chromatographic system: Proceed as directed in the Assay.
System suitability solution: 7.5 µg/mL of USP Pramipexole Dihydrochloride RS and 3 µg/mL of USP Pramipexole Related Compound A RS in Diluent
Standard solution: 1.5 µg/mL of USP Pramipexole Dihydrochloride RS in Diluent
Sample solution: 1.5 mg/mL of Pramipexole Dihydrochloride in Diluent
System suitability
Samples: System suitability solution and Standard solution
Suitability requirements
Resolution: NLT 6.0 between pramipexole related compound A and pramipexole, System suitability solution
Tailing factor: NMT 2.0 for pramipexole, System suitability solution
Relative standard deviation: NMT 5.0%, Standard solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of any individual impurity in the portion of Pramipexole Dihydrochloride taken:
Result = (rU/rS) × (CS/CU) × (Mr1/Mr2) × 100
rU = peak response of each impurity from the Sample solution
rS = peak response of pramipexole from the Standard solution
CS = concentration of USP Pramipexole Dihydrochloride RS in the Standard solution (mg/mL)
CU = concentration of pramipexole dihydrochloride monohydrate in the Sample solution (mg/mL)
Mr1 = molecular weight of pramipexole dihydrochloride, 284.26
Mr2 = molecular weight of pramipexole dihydrochloride monohydrate, 302.26
Acceptance criteria
Individual impurities: See Impurity Table 1.
Total impurities: NMT 0.5%
Impurity Table 1
Name Relative Retention Time Acceptance Criteria, NMT (%)
Pramipexole propionamidea 0.5 0.15
Pramipexole related compound Ab 0.7 0.15
Pramipexole 1.0 —
N-Propylpramipexolec 1.4 0.15
Pramipexole dimerd 1.7 0.15
Any other unidentified individual impurity — 0.10
a (S)-N-(2-Amino-4,5,6,7-tetrahydrobenzothiazol-6-yl)propionamide.
b (S)-4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
c (S)-2,6-Dipropylamino-4,5,6,7-tetrahydrobenzothiazole.
d N6,N6'-[2-Methylpentane-1,3-diyl]bis(4,5,6,7-tetrahydrobenzothiazole-2,6-diamine). This is a dimer of pramipexole (a mixture of four possible isomers).
SPECIFIC TESTS
• Water Determination, Method I <921>: NLT 4.5% and NMT 6.5%
• Enantiomeric Purity
Mobile phase: n-Hexane, dehydrated alcohol, and diethylamine (850:150:1)
System suitability stock solution: 1 mg/mL each of USP Pramipexole Dihydrochloride RS and USP Pramipexole Related Compound D RS in dehydrated alcohol
System suitability solution: 0.01 mg/mL each of USP Pramipexole Dihydrochloride RS and USP Pramipexole Related Compound D RS from System suitability stock solution in Mobile phase
Standard stock solution: 2.0 mg/mL of USP Pramipexole Related Compound D RS in dehydrated alcohol
Standard solution: 1.5 µg/mL of USP Pramipexole Related Compound D RS in Mobile phase
Sample solution: 0.3 mg/mL, prepared by dissolving a suitable weighed quantity of Pramipexole Dihydrochloride in 25% of a flask volume of dehydrated alcohol and diluting with Mobile phase to volume
Chromatographic system
(See Chromatography 621, System Suitability.)
Mode: LC
Detector: UV 254 nm
Column: 4.6-mm × 25-cm; 10-µm packing L51
Flow rate: 1.5 mL/min
Sample size: 75 µL
System suitability
Samples: System suitability solution [Note-The relative retention times for pramipexole related compound D (R-enantiomer) and pramipexole (S-enantiomer) are 0.5 and 1.0, respectively. ]
Suitability requirements
Resolution: NLT 5.0 between pramipexole related compound D and pramipexole, System suitability solution
Tailing factor: NMT 2.4 for pramipexole, System suitability solution
Analysis
Samples: Standard solution and Sample solution
Calculate the percentage of pramipexole related compound D in the portion of Pramipexole Dihydrochloride taken:
Result = (rU/rS) × (CS/CU) × 100
rU = peak response of pramipexole related compound D from the Sample solution
rS = peak response of pramipexole related compound D from the Standard solution
CS = concentration of pramipexole related compound D in the Standard solution (mg/mL)
CU = concentration of the Sample solution (mg/mL)
Acceptance criteria: NMT 1.0% of pramipexole related compound D
• Limit of Palladium
[Note-Perform this test if palladium is a known inorganic impurity. ]
Diluent: 0.1 M hydrochloric acid
Standard solution: 40 µg/L of palladium in Diluent, from commercially available palladium standard solution for atomic absorption/inductively coupled plasma. [Note—Freshly prepare this solution as required on the day of use. ]
Sample solution: To 0.5 g of Pramipexole Dihydrochloride in a 50-mL volumetric flask add 5.00 mL of 1 M hydrochloric acid, and dissolve with heating. Cool to room temperature, and dilute with water to volume.
Spectrometric conditions
(See Spectrophotometry and Light-Scattering 851).
Mode: Atomic absorption spectrophotometry
Analytical wavelength: Palladium emission line at 247.6 nm
Lamp: Hollow cathode
Atomization source: Graphite furnace. [Note—Follow the manufacturer’s recommended programming sequence. ]
Sample size: 20 µL
Blank: Diluent
System suitability
Sample: Standard solution
Suitability requirements
Absorbance: NLT 0.034
Analysis
Samples: Standard solution and Sample solution
Determine the concentration of palladium in the Sample solution by the standard addition method.
Acceptance criteria: NMT 5 ppm
ADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in well-closed containers, protected from moisture and light.
• USP Reference Standards 11
USP Pramipexole Dihydrochloride RS Click to View Structure
USP Pramipexole Related Compound A RS
(S)-4,5,6,7-Tetrahydrobenzothiazole-2,6-diamine.
C7H11N3S 169.25
USP Pramipexole Related Compound D RS
(R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole.
C10H17N3S 211.33
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| WGK Germany | 3 |
| RTECS | DL3375000 |
| HS Code | 2934 2000.90 |
Pramipexole Dihydrochloride Monohydrate (CAS: 191217-81-9) is an antihistamine. It is mainly used clinically to treat Parkinson's disease and its syndrome. It can be used alone or in combination with Levodopa. Pramipexole Dihydrochloride Monohydrate is a selective and blood-brain barrier (BBB) penetrant dopamine D2-type receptor agonist, with Kis of 2.2 nM, 3.9 nM, 0.5 nM and 1.3 nM for D2-type receptor, D2, D3 and D4 receptors, respectively. Pramipexole dihydrochloride hydrate can be used for the research of Parkinson's disease (PD) and restless legs syndrome (RLS).
1. Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").
2. Pramipexole is also used to treat a certain medical condition (restless legs syndrome - RLS) that causes an unusual urge to move the legs. Symptoms usually occur at night along with uncomfortable/unpleasant feelings in the legs. This medication can decrease these symptoms and thereby improve sleep.
