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Promethazine Hydrochloride

Promethazine hydrochlorine

CAS: 58-33-3

Molecular Formula: C17H21ClN2S

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Promethazine Hydrochloride - Names and Identifiers

Name Promethazine hydrochlorine
Synonyms PHENERGAN
promethiazin
PROMETHAZINE HCL
Promethazine HCl
PROMETHAZINE HYDROCHLORIDE
Promethazine Hydrochloride
Promethazine hydrochlorine
N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine
10-(2-dimethylamino-1-propyl)phenothiazine hydrochloride
10-(2-(dimethylamino)propyl)phenothiazinemonohydrochloride
10-(2-(dimethylamino)propyl)-phenothiazinmonohydrochloride
10H-phenothiazine-10-ethanamine, N,N,α-trimethyl-, chloride
promethazinen-(2'-dimethylamino-2'-methylethyl)phenothiazinehydrochloride
CAS 58-33-3
EINECS 200-375-2
InChI InChI=1/C17H20N2S.ClH/c1-13(18(2)3)12-19-14-8-4-6-10-16(14)20-17-11-7-5-9-15(17)19;/h4-11,13H,12H2,1-3H3;1H/p-1
InChIKey XXPDBLUZJRXNNZ-UHFFFAOYSA-N

Promethazine Hydrochloride - Physico-chemical Properties

Molecular FormulaC17H21ClN2S
Molar Mass320.88
Melting Point230-232°C
Boling Point403.7 °C at 760 mmHg
Flash Point9℃
Solubility Easily soluble in water, soluble in ethanol or chloroform, almost insoluble in acetone or ether
AppearanceWhite or off-white powder
ColorWhite to Almost white
Maximum wavelength(λmax)['297nm(H2O)(lit.)']
Merck14,7786
BRN4166397
PHpH (50g/L, 25℃) : 4.0~6.0
Storage Condition2-8°C
SensitiveSensitive to light
MDLMFCD00012652
UseApplicable to various allergic diseases and pregnancy Vomit

Promethazine Hydrochloride - Risk and Safety

Risk CodesR22 - Harmful if swallowed
R36/37/38 - Irritating to eyes, respiratory system and skin.
R51/53 - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. 
R43 - May cause sensitization by skin contact
R20/22 - Harmful by inhalation and if swallowed.
Safety DescriptionS26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S36 - Wear suitable protective clothing.
S61 - Avoid release to the environment. Refer to special instructions / safety data sheets. 
S60 - This material and its container must be disposed of as hazardous waste.
S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.
S28 - After contact with skin, wash immediately with plenty of soap-suds.
S22 - Do not breathe dust.
UN IDsUN 2811 6.1/PG 3
WGK Germany3
RTECSSO8225000
HS Code29343000
Hazard Class6.1(b)
Packing GroupIII
ToxicityLD50 i.v. in mice: 55.0 mg/kg (Rajsner)

Promethazine Hydrochloride - Reference

Reference
Show more
1. [IF=3.935] Yixuan Cui et al."A fast and simple approach for the quantification of five anti-hypersensitivity drugs in saliva and urine by portable ion mobility spectrometry based on magnetic graphene oxide dispersive solid phase extraction."J Pharmaceut Biomed. 2020

Promethazine Hydrochloride - Standard

Authoritative Data Verified Data

This product is (±)-N,N,a-trimethyl-10h-phenothiazine-10-ethylamine hydrochloride. The content of C17H20N2S • HCl shall not be less than 99.0% calculated on a dry basis.

Last Update:2024-01-02 23:10:35

Promethazine Hydrochloride - Trait

Authoritative Data Verified Data
  • This product is white or white-like powder or granules; Almost odorless; In the air, the day long deterioration, blue.
  • This product is easily soluble in water, soluble in ethanol or dichloromethane, and almost insoluble in propyl copper or ether.

absorption coefficient

take this product, precision weighing, plus O.Olmol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 6ug per lml, and the absorbance was measured at the wavelength of 249mn by UV-Vis spectrophotometry (General rule 0401), the absorption coefficient is 883 to 937.

Last Update:2022-01-01 15:04:29

Promethazine Hydrochloride - Differential diagnosis

Authoritative Data Verified Data
  1. take about 5mg of this product, add sulfuric acid 5ml to dissolve, the solution shows cherry red; After placement, the color gradient is deep.
  2. take about 0.1g of this product, add 3ml of water to dissolve, and then add 1ml of nitric acid to generate red precipitate; Heat, precipitate will dissolve, and the solution will change from red to orange.
  3. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 350).
  4. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update:2022-01-01 15:04:29

Promethazine Hydrochloride - Exam

Authoritative Data Verified Data

acidity

take 0.50g of this product, Add 10ml of water to dissolve, and measure according to law (General rule 0631). The pH value should be 4.0~5.0.


clarity and color of solution

take l.Og of this product, add 10ml of water to dissolve, the solution should be clear and colorless. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General rule 0902 first method); If it is colored, it should not be deeper compared with yellow No. 2 Standard Colorimetric solution (General rule 0901 first method).


Related substances

operation in the dark. Take this product, plus O. 1 mol/L hydrochloric acid solution is dissolved and diluted to make a solution containing about 0.2mg per 1 ml as a test solution; Take 1 ml for precision measurement, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the high performance liquid chromatography (General 0512) test, with eighteen alkyl silane bonded silica gel as filler, water (with glacial acetic acid to adjust the pH value to 2.3)-methanol (55:45) as mobile phase, the detection wavelength was 254nm. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should be greater than 2.0. 20 u1 of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component chromatographic peak. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).


loss on drying

take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).


ignition residue

not more than 0.1% (General rule 0841).

Last Update:2022-01-01 15:04:32

Promethazine Hydrochloride - Content determination

Authoritative Data Verified Data

take this product about 0.25g, precision weighing, add 0.01mol/L hydrochloric acid solution 5ml and ethanol 50ml to dissolve. Potentiometric titration (General 0701), with sodium hydroxide titration solution (0.lmol/L) titration, record the number of consumed milliliters V1 when the first burst occurs, continue titration until the number of consumed milliliters V2 when the second burst occurs, the difference between V and V1 is the volume of the consumed titration solution. Each 1 ml of sodium hydroxide titration solution (0.1 mol/L) corresponds to 32.09mg of C17H20N2S • HCl.

Last Update:2022-01-01 15:04:31

Promethazine Hydrochloride - Category

Authoritative Data Verified Data

antihistamines.

Last Update:2022-01-01 15:04:31

Promethazine Hydrochloride - Storage

Authoritative Data Verified Data

light shielding, sealed storage.

Last Update:2022-01-01 15:04:31

Promethazine Hydrochloride - Promethazine Hydrochloride Tablets

Authoritative Data Verified Data

This product contains promethazine hydrochloride (C17H20N2S • HCl) should be 93.0% ~ 107.0% of the label amount.


trait

This product is sugar-coated tablets, white to yellowish after removing the coating.


identification

  1. take this product, remove the coating, grind, weigh an appropriate amount (equivalent to 0.2g of promethazine hydrochloride), add 10ml of water, shake to dissolve promethazine hydrochloride, filter, the filtrate was evaporated to dryness on a water bath, and the residue showed the same reaction according to the tests of identification tests (1), (2) and (4) in the case of promethazine hydrochloride.
  2. take 5 tablets (50mg specification), 10 tablets (25mg specification) or 20 tablets (12.5mg specification) of this product, remove the coating, and place the mortar to grind it, add an appropriate amount of methanol-diethylamine (95:5) to dissolve promethazine hydrochloride and transfer to a 25ml measuring flask, dilute to the mark with the above solvent, shake and filter, the filtrate was taken as a test solution, and the promethazine hydrochloride control was additionally taken, dissolved and diluted with the above solvent to prepare a solution containing 10 mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of 10 u1, respectively, on the same silica gel GF254 thin layer plate, with ethane-acetone-diethylamine (8.5:1: 0.5) for the development of the agent, expand, dry, set the UV light (254nm) under the inspection. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
  3. 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.
  4. take an appropriate amount of fine powder of this product (about equivalent to isopropyl chloride lOOmg), add 10ml of chloroform, grind and dissolve, filter, evaporate the filtrate in water bath, dry the residue under reduced pressure, and determine it according to law (General rule 0402). The infrared absorption spectrum of this product should be consistent with the spectrum of the control (Spectrum set 3 5 0 figure).
  5. two items (2) and (3) above can be selected as one item.

examination

  • the related substances were protected from light. Take the filtrate under the content determination item as the test solution; Take 1ml of precision measurement, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of the test solution and the control solution are accurately measured, and the human liquid chromatograph is injected respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. 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 (1.0% ) , and the sum of each impurity peak area shall not be greater than 2 times the area of the main peak of the control solution (2.0%).
  • dissolution dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), hydrochloric acid solution (9-100) as the dissolution medium, the speed is rpm, operate in accordance with the law, after 45 minutes, take 10ml of solution, filter, take the appropriate amount of the precise amount of filtrate, and dilute it quantitatively with water to make a solution containing 5ug of promethazine hydrochloride per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General rule 910), and the elution amount of each tablet was calculated as the absorption coefficient of C17H20N2S · HCl was. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
  • others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

  • light-shielding operation. Determined by high performance liquid chromatography (General 0512).
  • chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler; Water (with glacial acetic acid to adjust the pH value to 2.3)-methanol (55:45) as mobile phase; the detection wavelength was 254mn. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should be greater than 2.0.
  • determination of 10 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (equivalent to 20mg promethazine hydrochloride), put in a 100ml measuring flask, add 0.lmol/L hydrochloric acid solution appropriate amount, shaking to dissolve promethazine hydrochloride and 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, filter, Take 5ml of filtrate accurately, put it in a 50ml measuring flask, dilute it to the scale with water, shake well, and use it as a test solution, accurately take 20u1 injection liquid chromatograph, record chromatogram; Another promethazine hydrochloride reference, precision weighing, add 0.1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 0.02mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.

category

with promethazine hydrochloride.


specification

(1)12.5mg (2)25mg (3)50mg


storage

light shielding, sealed storage.

Last Update:2022-01-01 15:04:33

Promethazine Hydrochloride - Promethazine Hydrochloride Injection

Authoritative Data Verified Data
  • This product is a sterilized aqueous solution of promethazine hydrochloride. The content of promethazine hydrochloride (C17H20N2S • HCl) shall be between 95.0% and 105.0% of the labeled amount.
  • This product can be added with an appropriate amount of vitamin C.

trait

This product is a clear colorless liquid.


identification

  1. 0.2ml of this product was taken and evaporated to dryness, and the residue showed the same reaction according to the test of identification items (1), (2) and (4) of promethazine hydrochloride.
  2. take 10ml of this product, put it in a 25ml measuring flask, add methanol-diethylamine (95:5) to dissolve and dilute to the scale, shake, as a test solution; another promethazine hydrochloride control was dissolved and diluted with methanol-diethylamine (95:5) to prepare a solution containing about 10 mg per 1 ml as a control solution. According to the thin layer chromatography (General 0502) test, absorb the above two solutions of each L01, respectively, on the same silica gel GF254 thin layer plate, with hexane-acetone-diethylamine (8.5:1:0.5) for the development of the solvent, expand, dry, set the UV light (254nm) under the view. The position and color of the main spot displayed by the test solution should be the same as that of the reference solution.
  3. 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.
  4. two items (2) and (3) above can be selected as one item.

examination

  • the pH value should be 4.0 to 5.5 (General 0631).
  • the related substances were protected from light. Take the stock solution of the test product under the item of content determination as the test solution; Take 1ml with precision, put it in a 100ml measuring flask, and use 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. According to the chromatographic conditions under the content determination item, 20 u1 of each of the test solution and the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is recorded to 3 times of the retention time of the main component peak. Take an appropriate amount of vitamin C, add 0.lmol/L hydrochloric acid solution to dissolve and dilute to make a solution containing 0.02mg per lml. Take 20u1 and inject human chromatograph to record the chromatogram. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area except the vitamin C peak shall not be greater than the main peak area of the control solution (1.0%).
  • bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg promethazine hydrochloride containing endotoxin amount should be less than 3.0 EU.
  • others should comply with the relevant provisions under injection (General 0102).

Content determination

  • light-shielding operation. Determined by high performance liquid chromatography (General 0512).
  • chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Water (with glacial acetic acid to adjust the p H value to 2.3)-methanol (55:45) as mobile phase; the detection wavelength was 254nm. The theoretical plate number is not less than 3000 according to the calculation of the promethazine hydrochloride peak, and the separation degree of the promethazine hydrochloride peak from the impurity peak with the relative retention time of 1.1 to 1.2 should be greater than 2.0.
  • determination of precision take an appropriate amount of this product (about 50mg equivalent to promethazine hydrochloride), put it in a 250ml volumetric flask, and use 0. Dilute 1 mol/L hydrochloric acid solution to the scale, shake well, as a sample stock solution, Take 5ml, put it in a 50ml measuring flask, dilute it to the scale with water, shake well, as the test solution, the sample was accurately measured by 20u1 injection liquid chromatograph, and the chromatogram was recorded. 1 mol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 0.02mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.

category

with promethazine hydrochloride.


specification

(l)lml:25mg (2)2ml:50mg


storage

light shielding, closed storage.

Last Update:2022-01-01 15:04:34

Promethazine Hydrochloride - Reference Information

EPA chemical substance information information provided by: ofmpeb.epa.gov (external link)
Overview promethazine hydrochloride, also known as Phenergan, is a commonly used clinical phenothiazine antihistamine, although clinical reports of its adverse reactions are not uncommon, but because of its clear role, low price, is still widely used in primary hospitals. Promethazine hydrochloride is the first found phenothiazine-like structure of tricyclic antihistamines, antitussive efficacy, able to competitively block the histamine H1 receptor and produce antihistamine effect, against histamine-induced telangiectasia, and reduce its permeability. As a result, Cough of those caused by tracheal irritation can be relieved.
pharmacokinetics absorption is fast and complete and protein binding is high after oral or injection administration. This product by oral or rectal administration after the onset time is 20 minutes, the general duration of antihistamine effect is 6-12 hours, the sedative effect can last for 2-8 hours. Mainly in the liver metabolism, inactive metabolites can be excreted by urine, fecal excretion of less.
pharmacological action promethazine is an antihistamine of the phenothiazine class, and can also be used for antiemetic, anti-halo, and sedative-hypnotic. 1. Antihistamine effect: it competes with histamine released from tissues for H1 receptor, and can antagonize the contraction or contracture of smooth muscle of gastrointestinal tract, trachea, bronchi or bronchioles by histamine, relieves the spasmogenic and hyperemic effect of histamine on bronchial smooth muscle. 2. Antiemetic effect: it may be related to the inhibition of emetic chemical sensing area of medulla oblongata. 3. Anti-motion sickness: it may act on the vestibular and Vomit Central and midbrain medullary receptors through central anticholinergic properties, mainly blocking the excitation of Cholinergic Synaptic labyrinth Impulse in the vestibular nucleus. 4, sedative hypnotic effect: may be due to indirectly reduce the brain stem network up the activation system of the stress.
indication 1. Skin and mucous membrane allergy: for long-term, seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis caused by contact with allergens or food, urticaria, angioedema, allergic reactions to blood or plasma products, scarification of skin. If necessary, it can be combined with epinephrine as an adjuvant of the drug. Motion sickness: prevention and treatment of motion sickness, seasickness and aircraft sickness.
3. Sedation and hypnosis: Applicable to preoperative, postoperative and obstetric. In addition, it can also be used to reduce the fear of adults and children, in a light sleep state.
Nausea, Vomit treatment: suitable for some anesthesia and surgery Nausea, Vomit, also for the prevention and treatment of radiation disease or drug-induced Nausea, Vomit.
5. Postoperative pain: it can be combined with pain medication as an adjuvant.
usage and dosage .
2. The dosage should be reduced at the time of dehydration or Oliguria to avoid toxic reaction.
3. When oral, can be taken with food or milk at the same time, in order to reduce the stimulation of gastric mucosa.
4. Adult usual dosage: Oral: ① anti-allergy, 12.5mg(0.5 tablets), 4 times a day, after meals and before going to bed, 25mg(1 tablet) before going to bed if necessary; ② antiemetic, at the beginning, 25mg(1 tablet) once, 12.5~25mg(0.5 ~ tablets) every 4~6 hours if necessary; ③ anti-vertigo, 25mg(1 tablet) once, sedation and hypnosis, 25~50mg(1~2 tablets), if necessary, double.
5. Children's usual dosage: Oral: ① anti-allergy, each time according to the weight of 0.125mg/kg or according to the body surface area of 3.75mg/m2, once every 4~6 hours, or according to the weight of 0.25~0.5mg/kg or according to the body surface area of 7.5~15mg/m2 before going to bed; According to The Age, the daily amount of 5~10mg within 1 year old, 1~5 years old 5~15mg,6 years old over 10~25mg, can be given once or twice, according to the body weight of 0.25 ~ 0.5mg/kg or according to the body surface area of 7.5 ~ 15mg/m2; If necessary, every 4~6 hours administration; ③ Anti vertigo, 0.25~0.5mg/kg of body weight or 7.5~15mg/m2 of body surface area; If necessary, every 12 hours, or 12.5~25mg, 2 times a day; ④ sedation and hypnosis, if necessary, 0.5 to 1 mg/kg of body weight or 15 to 30mg/m2 of body surface area.
adverse reactions promethazine belongs to phenothiazine derivatives, with no obvious side effects in small doses, however, the common side effects of thiazide can occur in large and long-term use.
1. Increase the sensitivity of the skin to light, more nightmares, easily excited, easily excited, hallucinations, toxic delirium, children prone to extrapyramidal reactions. The above reaction rate was not high.
2. Signs and symptoms of excessive dosage include: clumsiness or erratic movements of hands and feet, drowsiness or flushing in severe cases, Fever, shortness of breath or Dyspnea, increased heart rate [antimuscarinic (M) receptor effect], muscle cramps, especially in the neck and back muscles. Restlessness, difficulty walking, spasmodic twitching of the muscles of the head and face or tremor of the hands (the latter is extrapyramidal effect).
3. Care should be taken when the following conditions persist: somnolence is more common; Blurred vision or color blindness (mild) is less common; Dizziness, dry mouth and nasopharynx, tinnitus, rash, stomach pain or stomach discomfort, unresponsiveness (more common in children), Nausea or Vomit [with surgery and/or other drugs], and even jaundice. Rectal burning or tingling may occur when using suppositories.
4. Cardiovascular adverse reactions are rare, with increased blood pressure and occasional mild decrease in blood pressure. Leukopenia, granulocytopenia, and regenerating anemia are rare.
note 1. Skin allergy. Known to be highly allergic to phenothiazine drug patients, also allergic to this product.
2. Interference with diagnosis: increased glucose tolerance can be shown in glucose tolerance test. Can interfere with the urine pregnancy immune test, the results were false positive or false negative.
3. The following should be used with caution: acute asthma, bladder neck obstruction, myelosuppression, cardiovascular disease, Coma, angle-closure glaucoma, hepatic insufficiency, hypertension, gastric ulcer, prostatic hypertrophy, pyloric or Duodenal obstruction, respiratory diseases (especially in children, after taking this product sputum viscous, affecting expectoration, and can inhibit Cough reflex), epilepsy patients (injection administration can increase the severity of convulsions), jaundice, various liver diseases and renal failure, Reye syndrome (extrapyramidal symptoms due to promethazine are easily confused with Reye syndrome).
4. When using promethazine, special attention should be paid to whether there is intestinal obstruction, or drug overdose, poisoning and other problems, because its symptoms and signs can be covered by promethazine's antiemetic effect.
Use applies to a variety of allergic diseases and pregnancy Vomit.
indications: it can competitively block the Hl receptor of the group limbs to produce antihistamine effect, antagonize histamine-induced telangiectasia, reduce its permeability, and relieve wheezing caused by bronchial smooth muscle contraction, compared with diphenhydramine hydrochloride, the effect was strong and lasting.
Last Update:2024-04-10 22:29:15
Promethazine Hydrochloride
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Product Name: Promethazine Hydrochloride Visit Supplier Webpage Request for quotation
CAS: 58-33-3
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Mobile: +86-18621343501
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Hefei TNJ Chemical Industry Co.,Ltd.
Product Name: Promethazine hydrochlorine Request for quotation
CAS: 58-33-3
Tel: 0086-551-65418684
Email: sales@tnjchem.com
     info@tnjchem.com
Mobile: 0086 189 4982 3763
QQ: 2881500840 Click to send a QQ message
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Shanghai Macklin Biochemical Co., Ltd
Spot supply
Product Name: Promethazine Hydrochloride Visit Supplier Webpage Request for quotation
CAS: 58-33-3
Tel: +86-18821248368
Email: Int06@meryer.com
Mobile: +86-18821248368
QQ: 495145328 Click to send a QQ message
WhatsApp: +86-18821248368
Shanghai Yuanye Bio-Technology Co., Ltd.
Multiple SpecificationsSpot supply
Product Name: Promethazine Hydrochloride Visit Supplier Webpage Request for quotation
CAS: 58-33-3
Tel: 18301782025
Email: 3008007409@qq.com
Mobile: 18021002903
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Promethazine Hydrochloride
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