Clindmycin
clindamycinpalmitate hydrochloride
CAS: 25507-04-4
Molecular Formula: C34H64Cl2N2O6S
Clindmycin - Names and Identifiers
Clindmycin - Physico-chemical Properties
| Molecular Formula | C34H64Cl2N2O6S |
| Molar Mass | 699.85 |
| Melting Point | 141-143°C |
| Boling Point | 767.4°C at 760 mmHg |
| Flash Point | 417.9°C |
| Solubility | DMSO (Slightly), Methanol (Slightly) |
| Vapor Presure | 3.44E-27mmHg at 25°C |
| Appearance | Solid |
| Color | White to Off-White |
| Storage Condition | -20°C Freezer, Under Inert Atmosphere |
Clindmycin - Risk and Safety
| HS Code | 2941906000 |
Clindmycin - Standard
Authoritative Data Verified Data
This product is 7-chloro-6, 7, 8-trideoxy -6-( 1-methyl-trans-4-propyl-L-2-pyrrolidinylamino)-1-thio-L-threo-a-D-glycerol type-galactopyranosyl-2-palmitate hydrochloride. Clindamycin (C18H33C1N205S) shall not be less than 55.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
Clindmycin - Trait
Authoritative Data Verified Data
- This product is white or off-white powder.
- This product is soluble in ethanol and soluble in water.
Last Update：2022-01-01 15:04:49
Clindmycin - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
- The infrared absorption spectrum of this product should be consistent with that of the reference product (General rule 0402).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:04:49
Clindmycin - Exam
Authoritative Data Verified Data
acidity
take this product, add water to dissolve and dilute the solution containing about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 2.8~3.8.
Related substances
take an appropriate amount of this product, add methanol to dissolve and dilute to make a solution containing about 10 mg per 1 ml as a test solution; Take an appropriate amount for precision measurement, A solution containing about 0.2mg per 1 ml was prepared as a control solution by quantitative dilution with methanol. According to the high performance liquid chromatography (General 0512) determination, using octanosilane bonded silica gel as filler r mobile phase A is 0.005mol/L ammonium acetate solution-acetonitrile (50:50), the mobile phase B was acetonitrile, and the linear gradient elution was carried out according to the following table; The detection wavelength was 230mn. Take an appropriate amount of clindamycin palmitate reference, add methanol to dissolve and dilute to make a solution containing about 20mg per 1 ml, inject 20u1 into the liquid chromatograph, record the chromatogram, the retention time of the clindamycin palmitate peak is about 32 minutes, and the degree of separation between the clindamycin palmitate peak and the clindamycin B palmitate peak (relative retention time of about 0.96) should be not less than 3.0. 20ul of the test solution and the control solution were accurately measured and injected into the human liquid chromatograph respectively, and the chromatograms were recorded. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (2.0%), and the sum of each impurity peak area shall not be greater than 3.5 times (7.0%) of the area of the main peak of the control solution.. The peaks in the chromatogram of the test solution which were 0.05 times smaller than the main peak area of the control solution were ignored.
residual solvent
ethanol, ethyl acetate, acetone, acetonitrile, dichloromethane and trichloromethane take this product about 0.4g, precision weighing, top empty bottle, precision add N, N-dimethylformamide-water (1:4 )5ml to dissolve, seal, as a test solution; Another precision weighing ethanol, ethyl acetate, acetone, acetonitrile, dichloromethane and chloroform each appropriate amount, with N, N-dimethylformamide-water (1:4) quantitative dilution is made to contain ethanol about 0.2mg, ethyl acetate about 0.2mg, acetone about 0.2mg, acetonitrile about 33ug, A mixed solution of about 48ug of dichloromethane and about 5ug of trichloromethane, 5ml of which was accurately measured, was placed in a headspace bottle, sealed, and used as a reference solution. According to the determination method of residual solvent (General Principle 0861 second method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane as stationary liquid (or similar polarity) is the column, and the initial temperature is 60°C, hold for 10 minutes, then raise the temperature to 180°C at a rate of 20°C per minute for 2 minutes; The inlet temperature is 200°C; The detector temperature is 250°C; The equilibrium temperature of the headspace bottle is 90°C, the equilibration time was 30 minutes. Take the reference solution into the headspace, and the separation degree between the peaks of each component shall meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. The residual amounts of ethanol, ethyl acetate, acetone, acetonitrile, dichloromethane and trichloromethane were calculated by the peak area according to the external standard method.
toluene, pyridine and N,N-dimethylformamide
take an appropriate amount of this product, precision weighing, add methylene chloride to make a solution containing about 50mg per 1 ml, as a test solution; Another precision weighing toluene, pyridine and N, the appropriate amount of N-dimethylformamide was dissolved in dichloromethane and diluted quantitatively to prepare a solution containing toluene about 45ug, pyridine about 10ug and N,N-dimethylformamide about 44ml per lml, respectively, as a control solution. According to the determination method of residual solvent (General Principle 0861 third method), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane as stationary liquid (or similar polarity) is the column, the column temperature is 90°C, the inlet temperature was 200°C and the detector temperature was 250°C. Appropriate amount of reference solution is injected into human gas chromatograph, and the chromatogram is recorded. The separation degree between peaks of each component shall meet the requirements. The appropriate amount of the test solution and the reference solution was accurately measured, and the human gas chromatograph was injected respectively, and the chromatogram was recorded. According to the external standard method, the residual amount of toluene, pyridine and N,N-dimethylformamide shall be in accordance with the provisions.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 3.0%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.5%.
Last Update：2022-01-01 15:04:50
Clindmycin - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octylsilane as filler; Ammonium acetate solution (take 3.85g of ammonium acetate, add 5% acetic acid solution to dissolve and dilute to 0.21% ml)-sodium dioctyl succinate sulfonate methanol solution (4:96) for the mobile phase; The detector is a refractive index detector. Take clindamycin palmitate reference solution 20 u1, inject human liquid chromatography, record chromatogram, clindamycin palmitate peak retention time is about 15 minutes, the degree of separation between the clindamycin palmitate peak and the clindamycin B palmitate peak (relative retention time about 0.90) should be not less than 2.0.
assay
take an appropriate amount of this product, accurately weigh it, add the mobile phase to dissolve and quantitatively dilute it to make a solution containing about 18mg per 1 ml as the test solution, 2ou1 was injected into human liquid chromatograph, and the chromatogram was recorded. An appropriate amount of reference substance of clindamycin palmitate was taken and determined by the same method. According to the external standard method, the content of c18h33c1n205 s in the sample was calculated by the peak area.
Last Update：2022-01-01 15:04:51
Clindmycin - Category
Authoritative Data Verified Data
antibiotics.
Last Update：2022-01-01 15:04:51
Clindmycin - Storage
Authoritative Data Verified Data
sealed and stored in a cool and dry place.
Last Update：2022-01-01 15:04:51
Clindmycin - Clindamycin palmitate hydrochloride dry suspension
Authoritative Data Verified Data
This product contains clindamycin palmitate hydrochloride according to clindamycin (C18H33CIN2O5S) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is white-like granular matter; Aromatic.
identification
The same results were shown according to the identification (1) Test under the item of clindamycin hydrochloride palmitate.
examination
- acidity: Take appropriate amount of this product, add water to dissolve and dilute to make a suspension containing about 10 mg of clindamycin per lml, and determine it according to law (General rule 0631). The pH value should be 2.5~5.0.
- relevant substances: take an appropriate amount of the fine powder of this product, dissolve it with methanol and dilute it to make a solution containing about 5.7mg of clindamycin per 1 ml, filter it, and take the continued filtrate as the test solution; A solution containing about 114ug of clindamycin per 1 ml was prepared as a control solution by quantitatively diluting an appropriate amount with methanol. According to the method under the item of clindamycin palmitate hydrochloride. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.13) except for the peak with relative retention time less than 2.0%, the sum of each impurity peak area shall not be greater than 4 times (8.0%) of the main peak area of the control solution.
- dissolution: according to the dissolution and release determination method (General rule 0931 second method), 0.4% sodium dodecyl sulfate solution is used as the dissolution medium, and the rotation speed is 75 rpm, after 15 minutes, take the appropriate amount of solution, filter, take the filtrate as the test solution; Take the appropriate amount of clindamycin palmitate reference, precision weigh, dissolution medium was added to dissolve and quantitatively dilute to prepare a solution containing about 75ug of clindamycin per 1 ml as a control solution. Test according to the method under the content determination item, take 50ul of the test solution and the reference solution, respectively, inject the human liquid chromatograph, record the chromatogram, according to the external standard method to calculate the amount of dissolution of each bag by peak area. The limit is 70% of the labeled amount and shall be in accordance with the provisions.
- weight loss on drying this product shall be dried under reduced pressure at 60°C to constant weight, and the weight loss shall not exceed 2.0% (General rule 0831).
- other than sedimentation volume ratio (single dose package), should comply with the relevant provisions under the item of oral suspension (General Principle 0123).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 0.225g equivalent to clindamycin) accurately, put it in a 50ml measuring flask, add the mobile phase to dissolve and dilute to the scale, shake well, filter, and take the filtrate as the test solution; Take an appropriate amount of clindamycin palmitate control, A solution containing about 4.5mg of clindamycin per 1 ml was prepared by dissolving and quantitatively diluting with a mobile phase as a control solution. According to the method under the item of clindamycin palmitate hydrochloride, obtained.
category
with clindamycin palmitate hydrochloride.
specification
0.5g : 37.5mg (based on C18H33C1N205S)
storage
sealed and stored in a cool place.
Last Update：2022-01-01 15:04:52
Clindmycin - Clindamycin palmitate hydrochloride granules
Authoritative Data Verified Data
This product contains clindamycin palmitate hydrochloride according to clindamycin (C18H33C1N205S) calculation, should be 90.0% ~ 110.0% of the label amount.
trait
This product is soluble granules.
identification
The same results were shown according to the identification (1) Test under the item of clindamycin hydrochloride palmitate.
examination
- acidity: Take appropriate amount of this product, add water to dissolve and dilute to make a solution containing about 0631 mg of clindamycin per 1 ml, and measure it according to law (General Rule 2.5). The pH value should be 5.0.
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 2.0%, first method 1).
- others should comply with the relevant provisions under The granule (General Principle 0104).
Content determination
take the contents under the item of difference in loading amount, mix them evenly, weigh the appropriate amount accurately (about 0.225g equivalent to clindamycin), water was added for dissolution and quantitative dilution to prepare a solution containing about 9mg of clindamycin per 1 ml. After adding 10ml of human chloroform, add 1ml of sodium carbonate solution (30-100), fully shake for 15 minutes, centrifuge at 2500 rpm for 10 minutes, and discard the water layer, take 3ml of trichloromethane layer, put it in a 10ml measuring flask, dilute it to the scale with trichloromethane, shake it well, take 5ml precisely, put it in a dry tube, blow dry with nitrogen, add 1ml of mobile phase precisely, the residue was dissolved by shaking and used as the test solution. An appropriate amount of clindamycin palmitate reference product was taken, dissolved and quantitatively diluted with mobile phase to prepare a solution containing about 9mg of clindamycin per 1ml, as a control solution. According to the method under the item of clindamycin palmitate hydrochloride, obtained.
category
with clindamycin palmitate hydrochloride.
specification
Based on C18H33C1N2O5S (1)37.5mg (2)75mg(3 )0.9g
storage
sealed and stored in a cool and dry place.
Last Update：2022-01-01 15:04:53
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View History
Clindmycin
SODIUM PRASTERONR SULFATE
terbium
叶酸
procion black h-n
1355149-45-9
trans,trans-sorbic acid
374-01-6
40546-94-9
2424-98-8
SODIUM PRASTERONR SULFATE
terbium
叶酸
procion black h-n
1355149-45-9
trans,trans-sorbic acid
374-01-6
40546-94-9
2424-98-8