clindamycin phosphate
clindamycin phosphate
CAS: 24729-96-2
Molecular Formula: C18H34ClN2O8PS
clindamycin phosphate - Names and Identifiers
clindamycin phosphate - Physico-chemical Properties
| Molecular Formula | C18H34ClN2O8PS |
| Molar Mass | 504.96 |
| Density | 1.41±0.1 g/cm3(Predicted) |
| Melting Point | 114 °C |
| Boling Point | 159°C |
| Water Solubility | Freely soluble in water |
| Solubility | Soluble in water, and DMSO |
| Appearance | White solid |
| Color | White |
| Merck | 14,2356 |
| pKa | pKa 0.964±0.06(H2O t=21) (Uncertain);6.06 ±0.06 (I=0.008)(H2O t=21) (Uncertain) |
| Storage Condition | Sealed in dry,2-8°C |
| Stability | Stable, but store cool. Incompatible with strong oxidizing agents, calcium gluconate, barbiturates, magnesium sulfate, phenytoin, B group sodium vitamins. |
| Refractive Index | 122 ° (C=1, H2O) |
| MDL | MFCD07793328 |
| Use | Belongs to antibiotics |
clindamycin phosphate - Risk and Safety
| Risk Codes | R22 - Harmful if swallowed R36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | 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 | GF2625000 |
| HS Code | 29419000 |
clindamycin phosphate - Upstream Downstream Industry
| Raw Materials | Clindamycin |
clindamycin phosphate - Standard
Authoritative Data Verified Data
This product is 7-chloro-6, 7, 8-trideoxy -6- (1-methyl-trans-4-propyl-L-2-pyrrolidine formylamino)-1-thio-L-threonate-a-D-galactopyranosylglycoside -2-dihydrogen phosphate. Clindamycin (C18H33CIN2O5S) shall not be less than 77.0% calculated as anhydrous.
Last Update：2024-01-02 23:10:35
clindamycin phosphate - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; There is hygroscopicity.
- This product is soluble in water; Slightly soluble in methanol; Almost insoluble in ethanol and acetone.
specific rotation
take this product, precision weighing, water dissolution and quantitative dilution of about 10mg per lml solution, according to the law (General 0621), specific rotation of 115 ° to 130 °.
Last Update：2022-01-01 11:55:42
clindamycin phosphate - 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).
Last Update：2022-01-01 11:55:42
clindamycin phosphate - Exam
Authoritative Data Verified Data
crystallinity
take this product, determination according to law (General 0981), should comply with the provisions.
acidity
take this product, add water to make a solution containing about 10mg per lml, according to the law (General 0631),pH value should be 3.5~4.5.
clarity and color of solution
take 5 parts of this product, each l. After being dissolved by adding 20ml of water respectively, the solution should be clear and colorless; In case of turbidity, it should be compared with No. 2 Turbidity standard solution (General rule 0902 first method), neither shall be more concentrated (for non-injection or in comparison with No. 1 turbidity standard solution (General rule 0902 method 1), no deeper than the yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).
Related substances
take an appropriate amount of this product, weigh it accurately, add diluent [phosphate buffer (pH 3.9)] (take 3.5 of phosphoric acid, add 1000ml of water and concentrated solution; 2.5 of solution, adjust pH to 3.9±0.05 with concentrated ammonia solution as necessary)-90% acetonitrile in methanol (80:20)] dissolve and quantitatively dilute to make a solution containing about 3.57mg per 1 ml, as a test solution I, an appropriate amount of clindamycin phosphate reference substance was taken, dissolved with diluent and quantitatively diluted to prepare a solution containing about 3.57mg per 1 ml as a control solution (1)1 precise amount of control solution (1) appropriate amount, quantitative dilution with diluent to make a solution containing about 107ug per 1 ml, as a control solution (2); in addition, clindamycin control and lincomycin control were taken in appropriate amounts by close weighing respectively. Add control solution (2) to dissolve and quantitatively dilute to prepare a mixed solution containing clindamycin phosphate 107ug, clindamycin 30ug and lincomycin 6ug in each 1 ml. As a control solution. According to the determination of high performance liquid chromatography (General rule 0512), with eighteen alkyl silane bonded silica gel as filler (4.6mm x 3.9mm,5mm or equivalent column mobile phase A is phosphate buffer (pH)-90% acetonitrile methanol solution (92:8 ) , mobile phase B was phosphate buffer solution (pH 3.9)-90% acetonitrile methanol solution (52:48); The detection wavelength was 210mn; the column temperature was 40°C; The flow rate was 1.2ml per minute; Linear gradient elution was carried out as follows. Take the reference solution 5u1 and inject it into human liquid chromatograph, record the chromatogram, the retention time of clindamycin phosphate peak is about 20 minutes, and the elution order is lincomycin, clindamycin phosphate and clindamycin, the resolution between lincomycin peak and clindamycin phosphate peak, and between clindamycin phosphate peak and clindamycin peak should be greater than 30 and 6, respectively. The Control Solution (1)50u1 was injected into human liquid chromatograph, record chromatogram, impurity A peak (relative retention time is about 0.97) and clindamycin phosphate peak separation degree should be not less than 1.0. Then 50ul of the test solution and the reference solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of lincomycin and clindamycin, the content shall be calculated by the peak area according to the external standard method, and shall not exceed 0.2% and 0.5% respectively; if there is clindamycin B phosphate peak (relative retention time is about 0.75), impurity A peak and other impurity peaks, clindamycin phosphate peak area shall be calculated according to external standard method, clindamycin B Phosphate should not exceed 1.5% or 1.2% (for injection) (impurity A should not exceed 1.5% or 1.0% (other single impurities for injection should not exceed 0.5%); the total amount of other impurities should not exceed 2.0% or 1.0% (for injection). The peaks in the chromatogram of the test solution which were 0.02 times smaller than the main peak area of the control solution were ignored.
residual solvent
take this product about l. Add 2ml of water and 1 ml of 10% sodium hydroxide solution to dissolve, dilute with water to the scale, shake well, set 2ml of precision measurement into the top empty bottle, and seal, as a test solution; Take ethanol, acetone, chloroform and pyridine each appropriate amount, precision weighing, with 1% sodium hydroxide solution quantitative dilution made of ethanol in each lml about 25mg, the mixed solution of acetone 25mg, chloroform 0.3mg and pyridine 1 mg is used as the reference stock solution, quantitatively dilute with 1% sodium hydroxide solution to make a mixed solution containing about 0.5mg of ethanol, 0.5mg of acetone, 6ug of chloroform and 2ooug of pyridine in each lml, and take 2ml of density, top empty bottle, sealed, as a control solution. According to the determination method of residual solvent (General 0861), the capillary column with 6% cyanopropyl phenyl-94% dimethyl polysiloxane as stationary liquid (or similar polarity) is used as the column, the initial temperature is 50°C, and the maintenance time is 10 minutes, then the temperature was raised to 90°C at a rate of 10°C per minute and then to 210°C at a rate of 30°C per minute for 2 minutes; The temperature of the injection port was 250°C; the detector temperature was 300°C; The headspace bottle equilibration temperature was 10°C and the equilibration time was 15 minutes. Take the reference solution into the headspace, the separation degree between the peaks should meet the requirements. The test solution and the reference solution were injected by Headspace, and the chromatograms were recorded. The residual amounts of ethanol, acetone, chloroform and pyridine were calculated by the peak area according to the external standard method.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 6.0%.
abnormal toxicity
take this product, with the gasification of sodium injection made per lml containing clindamycin 5mg solution, according to the law (General Principles 1141), should comply with the provisions. (For injection)
antihypertensive substances
take this product, check according to law (General rule 1145), dose according to the cat weight per lkg injection 5mg (according to clindamycin), should comply with the provisions. (For injection)
bacterial endotoxin
take this product and check it according to law (General rule 1143). The amount of endotoxin in clindamycin per 1 mg should be less than 0.10EU. (For injection)
sterile
take this product, dissolve and dilute with 0.1% sterile peptone aqueous solution to make a solution containing about 20mg per 1 ml, and treat it by membrane filtration, wash with 0.1% sterile peptone aqueous solution (1000ml per membrane), use Staphylococcus aureus as positive control bacteria, check according to law (General rule 1101), should comply with the regulations. (For aseptic dispensing)
Last Update：2022-01-01 11:55:43
clindamycin phosphate - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
using octanosilane bonded silica gel as filler (4.6mm X 250mm,5mm or equivalent chromatographic column); With phosphate buffer (take potassium dihydrogen phosphate 13.61g, add water 1000ml to dissolve, the pH value was adjusted to 85% with 2.5 phosphoric acid solution)-acetonitrile (80:20) as mobile phase; The detection wavelength was 210mn. Take the reference solution (1) under the related substances inspection item 20ul injection human liquid chromatograph, record the chromatogram, impurity A peak (relative retention time is about 0.97) the degree of separation from the clindamycin phosphate peak should be no less than 1.0. In addition, weigh the appropriate amount of clindamycin phosphate reference substance and clindamycin reference substance respectively, add mobile phase to dissolve and dilute to make a mixed solution containing 0.3mg in each lml, and inject 10ul into human liquid chromatograph, the chromatogram was recorded. The clindamycin phosphate peak has a retention time of about 16 minutes, and the degree of separation between the clindamycin phosphate peak and the clindamycin peak should be greater than 6.0.
assay
precision weigh appropriate amount of this product, add mobile phase to dissolve and quantitatively dilute to make a solution containing about 0.3mg of clindamycin per 1 ml, as a sample solution, and inject 20ul into the liquid chromatograph with precision quantity, record the chromatogram; Take an appropriate amount of clindamycin phosphate reference substance, and determine by the same method. Calculate the content of c18h33c1n205 s in the sample by peak area according to external standard method.
Last Update：2022-01-01 11:55:44
clindamycin phosphate - Category
Authoritative Data Verified Data
antibiotics.
Last Update：2022-01-01 11:55:44
clindamycin phosphate - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 11:55:44
clindamycin phosphate - Clindamycin phosphate solution for external use
Authoritative Data Verified Data
This product contains clindamycin phosphate by clindamycin (C18H33CIN2O5S), should be 90.0% to 110.0% of the label children.
trait
This product is a clear colorless liquid.
identification
The same results were shown in the identification (1) Test under the item clindamycin phosphate.
examination
- the pH value should be 4.0 to 7.0 (General 0631).
- relevant substances: Take appropriate amount of this product and use diluent [phosphate buffer (pH 3.9)] (take 3.5 of phosphoric acid, add 1000ml of water and 2.5 of concentrated ammonia solution, adjust pH value to 3.9±0.05 with concentrated ammonia solution when necessary)-90% acetonitrile methanol solution (80:20)] quantitatively dilute to prepare a solution containing about 3mg of clindamycin per 1 ml as a test solution; A solution containing about 90ug of clindamycin per 1 ml was prepared as a control solution by quantitative dilution with diluent. In addition, each appropriate amount of the clindamycin reference substance and the lincomycin reference substance was accurately weighed separately, and the control solution was added to dissolve and quantitatively dilute to prepare a mixed solution containing clindamycin 30 ml and lincomycin 6ug per 1 ml, as a control solution. According to the method under the item of clindamycin phosphate, 50ug of the test solution, the reference solution and the control solution were accurately measured, and the human liquid chromatograph was injected respectively, and the chromatogram was recorded. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention times of lincomycin and clindamycin, the content thereof shall be calculated by the peak area according to the external standard method, and 0.5% and 2.0% of the labeled amount shall not be allowed respectively; the Peak area of other single impurities (except for the peak with relative retention time less than 0.2) shall not be more than 2.0% times () of the main peak area of the control solution, the sum of the peak areas of other impurities shall not be greater than 2 times (6.0%) the area of the main peak of the control solution. The peaks in the chromatogram of the test solution which were 0.02 times smaller than the main peak area of the control solution were ignored.
- microbial limit take this product as non-sterile product microbial limit test: microbial count method (General 1105) and control bacteria test method (General 1106) and non sterile drugs microbial limit standard (General 1107) inspection, should meet the requirements.
- others shall be in accordance with the relevant provisions under the item of paint (General rule 0118).
Content determination
precision take appropriate amount of this product, quantitative dilution with mobile phase to make a solution containing 0.3mg of clindamycin per 1 ml, as a test solution, according to the method under the item of clindamycin phosphate, that's right.
category
with clindamycin phosphate.
specification
Based on C18H33CIN2O5S (1) 20ml:0.2g(2)30ml:0.3g
storage
light-shielding, closed, stored in a cool place.
Last Update：2022-01-01 11:55:46
clindamycin phosphate - ClindamycinPhosphateInjection
Authoritative Data Verified Data
This product is a sterile aqueous solution of clindamycin phosphate. Clindamycin-containing phosphate shall be 90.0% to 110.0% of the labeled amount based on clindamycin (C18H33C1N205S).
trait
This product is colorless to yellowish clear liquid.
identification
The same results were shown in the identification (1) Test under the item clindamycin phosphate.
examination
- the pH value should be 5.5 to 7.0 (General 0631).
- color take 5 bottles of this product, respectively, with the yellow 2 Standard Colorimetric liquid (General Principles 0901 The first method), shall not be deeper D
- relevant substances: Take appropriate amount of this product and use diluent [phosphate buffer (pH 3.9)] (take 3.5 of phosphoric acid, add 1000ml of water and 2.5 of concentrated ammonia solution, adjust pH value to 3.9±0.05)-90% acetonitrile methanol solution (80:20) with concentrated ammonia solution when necessary] quantitatively dilute to prepare a solution containing about 3mg of clindamycin per 1 ml, as a test solution; An appropriate amount was taken in a precise amount and diluted quantitatively with a diluent to prepare a solution containing about 90ug of clindamycin per 1 ml as a control solution. In addition, the appropriate amounts of the clindamycin reference substance and the lincomycin reference substance were accurately weighed respectively, and the control solution was added to dissolve and quantitatively dilute to prepare a mixed solution containing about 30ug of clindamycin and lincomycin per 1 ml, which was used as the reference solution. According to the method under the item of clindamycin phosphate, the sample solution, the reference solution and the control solution of 50 u1 are accurately taken, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention time of lincomycin and clindamycin, the content thereof shall be calculated by the peak area according to the external standard method, and 0.2% and 1.5% of the labeled amount shall not be allowed respectively; the Peak area of other single impurities (except benzyl alcohol peak) shall not be greater than the main peak area of the control solution (3.0% ) , and the sum of the peak areas of other impurities shall not be greater than 2 times (6.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which were 0.02 times smaller than the main peak area of the control solution were ignored.
- take 1 ml of benzyl alcohol accurately, put it in a 200ml measuring flask, dilute it to scale with mobile phase, shake well, and use it as a sample solution. Weigh approximately 250mg benzyl alcohol accurately, add dimethyl sulfoxide (DMSO) (2.5ml) to 50ml measuring flask, dilute to scale with mobile phase, shake well, and take appropriate amount, quantitatively dilute with mobile phase to prepare a solution containing about 0.05mg per 1 ml, as a benzyl alcohol control solution; Accurately weigh an appropriate amount of clindamycin phosphate control, benzyl Alcohol Control Solution was added to dissolve and quantitatively dilute to prepare a mixed control solution containing about 0.75mg of clindamycin phosphate and 0.05mg of benzyl alcohol, respectively, per 1 ml. According to the chromatographic conditions under the content determination item, the mixed control solution 20u1 is injected into the human liquid chromatograph, and the chromatogram is recorded. The resolution between the clindamycin phosphate peak and the benzyl alcohol peak should be greater than 2.0. The sample solution and the benzyl alcohol control solution were respectively injected with 20 u1, and the chromatogram was recorded. If there is a peak of benzyl alcohol in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, and the content of benzyl alcohol in each 1 ml of this product shall not exceed 9.45mg. Abnormal toxicity, antihypertensive substances, bacterial endotoxin and clindamycin phosphate without seedling exposure under the inspection method, should be in accordance with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take appropriate amount of this product, and quantitatively dilute it with mobile phase to prepare a solution containing about 0.3mg of clindamycin per 1 ml, which is used as the test solution and determined according to the method under the item of clindamycin phosphate, that's right.
category
with clindamycin phosphate.
specification
Based on C18H33C1N205S (1) 2ml:0.15g(2)2ml:0.3g (3)4ml:0.6g (4)5ml:0.6g
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 11:55:47
clindamycin phosphate - Clindamycin phosphate suppositories
Authoritative Data Verified Data
This product contains clindamycin phosphate by clindamycin (c1833hcin2o5s) calculation, should be the label amount of 90.0% ~ 110.0%.
trait
This product is a white to yellowish suppository made of fatty matrix.
identification
- take an appropriate amount of this product (equivalent to clindamycin 0.12g), add 0.1 mol/L hydrochloric acid solution (5ml), heated in a water bath at 50-60°C to melt, filtered, and the filtrate (lml) was added with ammonium molybdate (10mg) to produce milky white precipitate; Then concentrated ammonia solution (lml) was added, the precipitate dissolved.
- the same results were shown in the identification (1) Test under the item clindamycin phosphate.
examination
- acidity: Take 2 grains of this product, add water to 20ml, heat them in a water bath at 40-50°C to melt, cool, filter, take the filtrate, and measure it according to law (General rule 0631), the pH should be between 3.0 and 5.0.
- relevant substances take an appropriate amount of this product (about 0.3g equivalent to clindamycin), weigh it accurately, put it in a 100ml measuring flask, and add diluent [phosphate buffer solution (pH 3.9)(Take 3.5ml of phosphoric acid, add 1.5ml of water and 3.9±0.05 ml of concentrated ammonia solution, adjust pH value to 90% with concentrated ammonia solution if necessary)-acetonitrile methanol solution (80:20)] appropriate amount, place it in a 40-50°C water bath and heat it to melt, shake it, cool it, dilute it to the scale with the above diluent, shake it well, filter it, and take the continued filtrate as the test solution; A solution containing about clindamycin per 1 ml was prepared as a control solution by quantitatively diluting an appropriate amount with the above diluent. In addition, the appropriate amounts of the clindamycin reference substance and the lincomycin reference substance were accurately weighed respectively, and the control solution was added to dissolve and quantitatively dilute to prepare a mixed solution containing clindamycin 30ug and lincomycin 6ug per 1 ml, which was used as the reference solution. According to the method under the item of clindamycin phosphate, 50 μl of each of the test solution, the reference solution and the control solution are accurately taken and injected into the liquid chromatograph respectively, and the chromatograms are recorded. If there are chromatographic peaks in the chromatogram of the test solution that are consistent with the retention times of lincomycin and clindamycin, the content thereof shall be calculated by the peak area according to the external standard method, and 0.5% and 1.0% of the labeled amount shall not be allowed respectively; the Peak area of other single impurities (except for the peak with relative retention time less than 0.2) shall not be more than 2 /3 times (2.0%) of the main peak area of the control solution, the sum of the peak areas of other impurities shall not be greater than 2 times (6.0%) the area of the main peak of the control solution. The peaks in the chromatogram of the test solution which were 0.02 times smaller than the main peak area of the control solution were ignored.
- microbial limit take this product as non-sterile product microbial limit test: microbial count method (General 1105) and control bacteria test method (General 1106) and non sterile drugs microbial limit standard (General 1107) inspection, should meet the requirements.
- others should comply with the relevant provisions under suppository (General rule 0107).
Content determination
take an appropriate amount of this product (about 30mg equivalent to clindamycin), weigh it accurately, put it in a 100ml measuring flask, add an appropriate amount of mobile phase, place it in a 40-50°C water bath and heat it to melt, shake, cool, add the mobile phase to the scale, shake, filter, take the filtrate, as a test solution, according to the method under the item of clindamycin phosphate, obtained.
category
with clindamycin phosphate.
specification
0.lg (based on C18H33CIN2O5S)
storage
shade, close, and store in a cool place.
Last Update：2022-01-01 11:55:48
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Raw Materials for clindamycin phosphate