Active Pharmaceutical Ingredients

64-75-5 – Names and Identifiers

Name	Tetracycline Hydrochloride
Synonyms	alatet cyclopar artomycin cancycline-250 Tetracycline hcl cefracyclinetablets amycin,hydrochloride chlorowodorkutetracykliny Tetracycline Hydrochloride chlorhydratedetetracycline (2E,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trione hydrochloride (2Z,4S,4aS,5aS,6S,12aS)-2-[amino(hydroxy)methylidene]-4-(dimethylamino)-6,10,11,12a-tetrahydroxy-6-methyl-4a,5a,6,12a-tetrahydrotetracene-1,3,12(2H,4H,5H)-trione hydrochloride [4S-(4alpha,4aalpha,5aalpha,6beta,12aalpha)]-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride
CAS	64-75-5 1170-81-6
EINECS	200-593-8
InChI	InChI=1/C22H24N2O8.ClH/c1-21(31)8-5-4-6-11(25)12(8)16(26)13-9(21)7-10-15(24(2)3)17(27)14(20(23)30)19(29)22(10,32)18(13)28;/h4-6,9-10,15,25,27-28,31-32H,7H2,1-3H3,(H2,23,30);1H
InChIKey	XMEVHPAGJVLHIG-FMZCEJRJSA-N

64-75-5 – Physico-chemical Properties

Molecular Formula	C22H25ClN2O8
Molar Mass	480.9
Melting Point	220-223°C(lit.)
Boling Point	799.4°C at 760 mmHg
Specific Rotation(α)	-252 º (c=0.5, H2O)
Flash Point	437.3°C
Water Solubility	50 g/L
Solubility	20g/L water, 5g/L ethanol, insoluble in ether, hydrocarbon and acetone.
Vapor Presure	5.82E-27mmHg at 25°C
Appearance	Yellow crystal
Color	faint yellow to yellow
Merck	14,9196
BRN	3844873
PH	pH(10g/l, 25℃) : 1.8～3.0
Storage Condition	Keep in dark place,Inert atmosphere,Store in freezer, under -20°C
Stability	Stable. Incompatible with strong oxidizing agents.
Sensitive	Air & Light Sensitive
Refractive Index	-253 ° (C=0.5, 0.1mo
MDL	MFCD00078142
Use	Broad-spectrum antibiotics

64-75-5 – Risk and Safety

Risk Codes	R36/37/38 – Irritating to eyes, respiratory system and skin. R20/21/22 – Harmful by inhalation, in contact with skin and if swallowed.
Safety Description	S26 – In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S36 – Wear suitable protective clothing.
UN IDs	UN 3077 9 / PGIII
WGK Germany	2
RTECS	QI9100000
FLUKA BRAND F CODES	8-10-23
TSCA	Yes
HS Code	29413000
Hazard Class	3
Toxicity	LD50 orally in rats: 6443 mg/kg (Goldenthal)

64-75-5 – Reference

Reference

1. Wang Yu, Xu Jia, heading for Su Yu, Zhao Ge, Jiang Jingyan. Effects of three kinds of antimicrobial agents commonly used in veterinary clinic on urease and its mechanism of action by spectroscopic and molecular docking [J]. Journal of Nanjing Agricultural University, 2020,43(04):690-697. 2. Zhou Rui, Gui Rongjie, Zhang Jin, etc. Screening of cadmium and tetracycline contaminated soil tolerant strains and their ability to promote rhizosphere growth. 3. Xue Xiaoxu, Chen Changze, Gu Guowei. Adsorption of drug active compounds on magnetic chitosan composite microspheres modified by polyacrylic acid [J]. Yunnan chemical industry, 2020,47(08):48-51. 4. Wang Shihao, Shi Minghao, Liu Su. Combined toxic effects of tetracycline and arsenic on zebrafish in sequential exposure scenarios [J]. Journal of Environmental Science, 2020,40(12):4590-4597. 5. He Qian, Wang Loli, Yi Chuan, Wu Guiping. Preparation of MoS_2 @ MIL-53(Fe) and its photocatalytic degradation of antibiotics under visible light [J]. Environmental Science & Technology, 2020,43(08):13-19. 6. Xue Xiaoxu, Chen Changze, Gu Guowei. Adsorption of drug active compounds on magnetic chitosan composite microspheres modified by polyacrylic acid [J]. Yunnan chemical industry, 2020,47(08):48-51. 7. [IF = 7.658] Hong Zhang et al.”Uncariitannin, a polyphonic polymer from Uncaria gambier, attenuates New York USA through an MgrA-mediated review of alpha-hemolysin.” Pharmacol Res. 2019 Sep;147:104328 8. [IF = 7.514] Baoshan He et al.”Aptamer-based thin film gold electrode modified with gold nanoparticles and carboxylated multi-walled carbon nanotubes for detecting oxytetracycline in chicken samples.”Food Chem. 2019 Dec;300:125179 9. [IF=7.514] Yanan Cao et al.”Rapid and selective extraction of norfloxacin from milk using magnetic molecular imprinting polymers nanoparticles.”Food Chem. 2021 Aug;353:129464 10. [IF=7.086] Zhifen Chen et al.”In-situ synthesis of biochar modified PbMoO4: An efficient visible light-driven photocatalyst for tetracycline removal.”Chemosphere. 2021 Dec;284:131260 11. [IF=6.291] Yilin Liu et al.”Responses of Hydrocharis dubia (Bl.) Backer and Trapa bispinosa roxb. to tetracycline exposure.”Ecotox Environ Safe. 2020 Oct;202:110890 12. [IF=3.209] Liuliu Jiang et al.”In vitro and in vivo evaluation of the antifungal activity of fluoxetine combined with antifungals against Candida albicans biofilms and oral candidiasis.”Biofouling. 2020;36(5):537-548 13. [IF=2.478] Wang Lina et al.”Palygorskite/g-C3N4 conjunction for visible-light-driven degradation of tetracycline hydrochloride.”J Mater Sci-Mater El. 2019 Oct;30(19):18159-18167 14. [IF=5.316] Peiyu Cao et al.”Constructing nano-heterojunction of MOFs with crystal regrowth for efficient degradation of tetracycline under visible light.”J Alloy Compd. 2022 May;904:164061 15. [IF=8.067] Yuanting Xu et al.”“1 1>2”: Highly efficient removal of organic pollutants by composite nanofibrous membrane based on the synergistic effect of adsorption and photocatalysis.”J Mater Sci Technol. 2022 Oct;124:76

64-75-5 – Standard

(4S,4aS,5aS,6S,12aS)-6-methyl -4-(dimethylamino)-3,6,10,12, 12a-pentahydroxy-1, 11-dioxo-1, 4 ,4a ,5 ,5a ,6 ,11 ,12a-A hydrogen-2-and tetrabenzamide hydrochloride. Tetracycline hydrochloride (C22H24N208 • HCl) shall not be less than 95.0% calculated on a dry basis.

64-75-5 – Trait

• This product is yellow crystalline powder; No odor; Slight hygroscopicity; In case of light color gradient deep, easy to destroy failure in alkaline solution.
• This product is dissolved in water, slightly soluble in ethanol, insoluble in ether.

---

specific rotation

take this product, precision weighing, add 0. The Olmol/L hydrochloric acid solution was dissolved and quantitatively diluted to prepare a solution containing about 10 mg per 1 ml, which was measured according to law (General rule 0621), and the specific rotation was from one 240 ° to one 258 °.

64-75-5 – Differential diagnosis

1. take about 0.5mg of this product, add 2ml sulfuric acid, that is deep purple, plus 1 drop of ferric chloride solution, the solution turned red-brown.
2. 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.
3. The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 332).
4. the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).

64-75-5 – Exam

acidity

take this product, add water to make a solution containing about 10 mg per lml, and determine it according to law (General 0631). The pH value should be 1.8~2.8.

---

clarity of the solution

take 5 parts of this product, 50mg each, respectively, add 5ml of water to dissolve, the solution should be clear; If it is turbid, compare with No. 1 turbidity standard solution (General rule 0902 first method), none should be more concentrated. (For injection)

---

Related substances

new system for clinical use. Take this product, plus O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to make a solution containing about 0.8mg per 1 ml as a test solution; 2ml is accurately measured, and 100ml is placed in a measuring flask, and 0.Olmol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. Take 2ml of the control solution, put it in a 100ml measuring flask, dilute it to the scale with 0.Olmol /L hydrochloric acid solution, and shake it to be used as a sensitivity solution. According to the chromatographic condition test under the content determination item, the sensitivity solution 10u1 is injected into the human liquid chromatograph, and the chromatogram is recorded. The signal-to-noise ratio of the peak height of the principal component chromatogram should be greater than 10. Then the l0ul 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 2.5 times of the retention time of the main component peak, if there are impurity peaks in the chromatogram of the test solution, the peak areas of oxytetracycline, 4-episomal tetracycline, chlortetracycline hydrochloride, dehydrated tetracycline and episomal dehydrated tetracycline shall be corrected (multiplied by the correction factor 1.0, respectively), 1.42, 1.39, 0.48 and 0.62) shall not be greater than 0.25 times (0.5% ) , 1.5 times (3.0%), 0.5 times (1.0%), 0.25 times (0.5%) of the main peak area of the control solution, 0.25 times (0.5% ) , and the sum of other impurity peak areas shall not be greater than 0.5 times (1.0%) of the main peak area of the control solution. The peaks in the chromatogram of the test solution which are smaller than the main peak area of the sensitivity solution are ignored.

---

absorbance of impurities

take this product, at 20~25°C, add 0.8% sodium hydroxide solution to make a solution containing 10 mg per 1 ml, according to UV-visible spectrophotometry (General 0401), put 4cm absorption cell, add 0.8% sodium hydroxide solution from 5 minutes, measured at a wavelength of 530nm, absorbance should not exceed 0.12 (for injection).

---

loss on drying

take this product, dry to constant weight at 105°C, weight loss should not exceed 1.0% (for oral use) or 0.5% (for injection) (General 0831).

---

pyrogen

take this product, add sodium chloride injection to make a solution containing 5mg per lml, check according to law (General rule 1142), dose according to rabbit body weight per lkg slow injection of 2ml, should meet the requirements. (For injection)

---

sterile

take this product, dissolve and dilute with appropriate solvent, after membrane filtration treatment, inspection according to law (General rule 1101), should comply with the provisions. (For aseptic dispensing)

64-75-5 – Content determination

measured by high performance liquid chromatography (General 0512).

---

chromatographic conditions and system suitability test

silica gel bonded with octylsilane as filler; Ammonium acetate solution [0.15mol/L ammonium acetate solution -0.01mol/L ethylene diamine tetraacetic acid disodium solution-triethylamine (100:10:1), with acetic acid to adjust the pH value to 8.5]-acetonitrile (83:17) as mobile phase; Detection wavelength was 280nm. Take about 3mg of the 4-poor tetracycline control, oxytetracycline control, poor dehydrated tetracycline control, chlortetracycline hydrochloride control and dehydrated tetracycline control, and about 48mg of the tetracycline hydrochloride control, and put them in a 100ml measuring flask, add 0.lmol /L hydrochloric acid solution (10ml) was dissolved, diluted to scale with water, and then shaken well. As the applicable solution for the system, 10u1 was injected into the liquid chromatograph, and the chromatogram was recorded: 4-EPI-tetracycline, oxytetracycline, epi-dehydrated tetracycline, tetracycline, chlortetracycline, dehydrated tetracycline, retention time of the tetracycline peak is about 14 minutes. 4-the separation degree between tetracycline peak, oxytetracycline peak, tetracycline peak, tetracycline peak and chlortetracycline peak shall meet the requirements, and the separation degree between chlortetracycline peak and tetracycline peak shall be greater than 1.0.

---

assay

take this product about 25mg, precision weighing, put 50ml measuring bottle, add 0. Dissolve and dilute the Olmol/L hydrochloric acid solution to the scale, shake well, take 5ml accurately, put it in a 25ml measuring flask, dilute to the scale with 0.01mol/L hydrochloric acid solution, shake well, as a sample solution, the sample was accurately measured by injection of 10u1 into human liquid chromatograph, and the chromatogram was recorded. An appropriate amount of tetracycline hydrochloride reference substance was taken and determined by the same method. According to the external standard method to calculate the peak area, that is.

64-75-5 – Category

Tetracycline antibiotics.

64-75-5 – Storage

shade, seal or seal, and store in a dry place.

64-75-5 – Hydrochloric acid Tetracycline Tablets

This product contains tetracycline hydrochloride (C22H24N208 • HCI) should be 90.0% to 110.0% of the label.

---

trait

This product is yellow or sugar-coated.

---

identification

take an appropriate amount of fine powder of this product (about 25mg of tetracycline hydrochloride), Heat 25ml of ethanol, soak it for 20 minutes, then filter it, and let the filtrate dry on a water bath, the same results were obtained according to the tests (1), (2) and (4) for the identification of the residue under the tetracycline hydrochloride.

---

examination

• Related substances take an appropriate amount of fine powder of this product and add O.Olmol/L hydrochloric acid solution was dissolved and diluted to make a solution containing about 0.8mg of tetracycline hydrochloride per 1 ml, filtered, and the filtrate was taken as the test solution, 4-Peak area after correction for episodic tetracycline, dehydrated tetracycline, episodic dehydrated tetracycline (multiplied by correction factor 1.42,0.48 and 0.62, respectively) respectively shall not be greater than 4 times (8.0%), 0.5 times (1.0%), 0.5 times (1.0%) of the main peak area of the control solution.
• the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), with water as the dissolution medium, the speed is 100 rpm, according to the law, 60 minutes, take the appropriate amount of solution, filtering, precision take the appropriate amount of filtrate, quantitative dilution of water to make the solution containing about 15ug of tetracycline hydrochloride in each lml; according to UV-visible spectrophotometry (General rule 0401), determine the absorbance at the wavelength of 276mn, and take an appropriate amount of tetracycline hydrochloride reference substance, water was added to dissolve and quantitatively diluted to prepare a solution containing about 15ug per 1 ml, which was determined by the same method, and the dissolution amount of each tablet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions. (Sugar-coated tablets)
• others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

---

Content determination

Take 10 tablets of this product, precision weighing, fine grinding, precision weighing appropriate amount (about 0.25g equivalent to tetracycline hydrochloride), put it in a 250ml measuring flask, add 0.01mol/L hydrochloric acid solution to dissolve and dilute to the scale, shake well, filter, accurately take 5ml of continued filtrate, put it in a 50ml measuring flask, diluted with 0.01mol/L hydrochloric acid solution to the scale, shake, as a test solution, according to the method under the item of tetracycline hydrochloride, obtained.

---

category

with tetracycline hydrochloride.

---

specification

(l)0.125g (2)0.25g

---

storage

light-shielded, sealed, and stored in a dry place.

64-75-5 – Tetracvcline Hvdrochloride Capsules

This product contains tetracycline hydrochloride (C22H24N208 • HCl) should be 90.0% to 110.0% of the label.

---

identification

The content of this product was taken, and the same results were shown according to the tests of (1), (2) and (4) under the items of tetracycline hydrochloride.

---

examination

• the contents under the item of difference in loading amount of related substances shall be mixed evenly, and the appropriate amount shall be accurately weighed and O shall be added. Olmol /L hydrochloric acid solution was dissolved and diluted to prepare a solution containing about 0.8mg of tetracycline hydrochloride per 1 ml, filtered, and the filtrate was taken as a test solution. Determined according to the method under tetracycline hydrochloride, the peak areas of 4-isotetracycline, anhydrotetracycline and anhydrotetracycline were corrected (multiplied by the correction factors 1.42,0.48 and 0.62, respectively) respectively shall not be greater than 4 times (8.0%), 0.5 times (1.0%), 0.5 times (1.0%) of the main peak area of the control solution.
• weight loss on drying the contents of this product shall be taken and dried at 105°C to constant weight, and the weight loss shall not exceed 2.5% (General rule 0831).
• the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method) with water as the dissolution medium, the speed is 75 rpm, according to the law, 60 minutes, take an appropriate amount of the solution, filter, take an appropriate amount of filtrate, dilute quantitatively with water to make a solution containing about 15ug of tetracycline hydrochloride per lml; According to UV-Vis spectrophotometry (General 0401), determine the absorbance at the wavelength of 276mn, take an appropriate amount of tetracycline hydrochloride reference, accurately weigh, add water to dissolve and quantitatively dilute to make a solution containing about 15ug per lml, and determine with the same method, the amount of dissolution of each pellet was calculated. The limit is 75% of the labeled amount and shall be in accordance with the provisions.
• others should comply with the relevant provisions under the capsule (General 0103).

---

Content determination

take the contents under the difference of loading amount, mix evenly, weigh appropriate amount (about 0.25g equivalent to tetracycline hydrochloride) accurately, and add O.Olmol /L hydrochloric acid solution was dissolved and quantitatively prepared to contain about 0.1 mg of the solution was filtered, and the filtrate was taken. As a test solution, it was obtained by measuring according to the method described in the case of tetracycline hydrochloride.

---

category

with tetracycline hydrochloride.

---

specification

0.25g

---

storage

light-shielded, sealed, and stored in a dry place.

64-75-5 – Tetracycline hydrochloride for injection

This product is tetracycline hydrochloride plus the right amount of vitamin C or citric acid as a stabilizer of sterile powder. The content of tetracycline hydrochloride (C22H24N208 • HCl) shall be between 93.0% and 107.0% of the labeled amount calculated as the average loading.

---

trait

This product is yellow mixed with white crystalline powder.

---

identification

This product was taken and the same results were shown according to the tests of (1), (2) and (4) under the items of tetracycline hydrochloride.

---

examination

• clarity of solution take 5 bottles of this product, and add water to make a solution containing about 10 mg per 1 ml according to the indicated amount. The solution should be clear, if it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 first method), shall not be more concentrated.
• relevant substances the contents of this product under the item of difference in loading amount shall be mixed evenly and the appropriate amount shall be accurately weighed, dissolve and dilute with 0.01mol/L hydrochloric acid solution to make a solution containing about 0.8mg of tetracycline hydrochloride per 1 ml. As the test solution, the method for the determination of tetracycline hydrochloride should be consistent with the regulations.
• weight loss on drying this product shall be dried at 105°C to constant weight, and the weight loss shall not exceed 0.8% (General rule 0831).
• the acidity, absorbance of impurities, Pyrogen and sterility shall be checked according to the method under tetracycline hydrochloride, and shall be in accordance with the regulations.
• others should comply with the relevant provisions under injection (General 0102).

---

Content determination

The content under the item of loading amount difference was accurately weighed and an appropriate amount was measured according to the method under the item of tetracycline hydrochloride, and the content was obtained.

---

category

with tetracycline hydrochloride.

---

specification

(1)0.125g (2)0.25g (3)0.5g

---

storage

It was kept in a dry place and closed.

Disclaimer: The above content is for reference and communication only among industry insiders, and does not guarantee its accuracy or completeness. According to relevant laws and regulations and the regulations of this website, units or individuals who purchase related items should obtain valid qualifications and qualification conditions.

If you're ready to take the next step, Leave your message below and we’ll reply soon. 20+ years of chemical manufacturing & export experience, a partner you can trust.