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ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 7732-18-5, Distilled water, Dihydrogen oxide, Sterile water, Purified water, Water vapor
Molecular Formula
H2O
Molecular Weight
18.015  g/mol
InChI Key
XLYOFNOQVPJJNP-UHFFFAOYSA-N
FDA UNII
059QF0KO0R

Water
A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)
1 2D Structure

Water

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
oxidane
2.1.2 InChI
InChI=1S/H2O/h1H2
2.1.3 InChI Key
XLYOFNOQVPJJNP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
O
2.2 Other Identifiers
2.2.1 UNII
059QF0KO0R
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Hydrogen Oxide

2.3.2 Depositor-Supplied Synonyms

1. 7732-18-5

2. Distilled Water

3. Dihydrogen Oxide

4. Sterile Water

5. Purified Water

6. Water Vapor

7. Water, Deionized

8. Oxidane

9. Water, Purified

10. Oxygen Atom

11. Dihydrogen Monoxide

12. Aqua

13. Steam

14. Dhmo

15. Deionized Water

16. Water For Injection

17. Sterile Water For Irrigation

18. Sterile Purified Water

19. Water For Hemodialysis

20. Ccris 6115

21. 1,3-epoxy-

22. Water, Purified Sterile

23. Water, Sterile Purified

24. Water Purified

25. Sterile Water For Injection

26. Sterile Water For Inhalation

27. Ultrex Ii Ultrapure

28. Water For Inhalation, Sterile

29. Water, Hplc

30. Water, Hplc Grade

31. H2o

32. Water, Depc-treated

33. Deuterium Cdepleted Water

34. Mfcd00011332

35. Nsc-147337

36. 059qf0ko0r

37. Chebi:15377

38. Water, Mineral

39. Water, For Hplc

40. Water, D.i.u.f.

41. Nsc 147337; R 718

42. R-718

43. Water, Sterile

44. Water, Distilled

45. Detergent, Neutral Reagent

46. Hoh

47. Deionized Ultra-filtered Water

48. 20% Acetonitrile/80% Water

49. Hydrochloric Acid Solution, 6n

50. Agua

51. Water, Sterile-filtered, Bioreagent, Suitable For Cell Culture

52. Aqua Purificata

53. Pur-wash

54. Ipa (isopropyl Alcohol), 70% V/v

55. Hydrochloric Acid, 25% (v/v) (1+3)

56. Buffer Solution, Ph 10.00, Color-coded Blue

57. Sterile Water In Plastic Container

58. Einecs 231-791-2

59. Nsc 147337

60. Acqua

61. Dihydridooxygen

62. (tris)-1, 10-phenanthroline Iron (ii) Sulfate Solution

63. Unii-059qf0ko0r

64. Water For Injection, Sterile

65. Adelheidsquelle

66. Tritiotope

67. Wiesbaden

68. Wasser

69. Water For Irrigation, Sterile

70. Hydroxy Radical

71. Water,deionized

72. Water,distilled

73. Water,sanitized

74. Adelheid Aqua

75. Aqua Adelheid

76. Aqua Wiesbaden

77. Water,purified

78. Water,sterile

79. Wiesbaden Aqua

80. Aqua Wildbad

81. Wildbad Aqua

82. Water-

83. Di Water

84. Hsdb 8183

85. Hydrogen Hydroxide

86. Bacteriostatic Water For Injection

87. Sterile Water For Injection In Plastic Container

88. Water For Injection, Bacteriostatic

89. Aqua Pro Injectione

90. Eau

91. Pure Water Density Standard, Ukas Iso/iec17025 And Iso Guide 34 Certified, Density: 0.9982 G/ml At 20 C, Density: 0.9970 G/ml At 25 C

92. Water,bacteriostatic

93. Water For Injections

94. Water, Acs Reagent

95. Water, Hplc Plus

96. Water, Lcms Grade

97. Aquafina

98. Water, Pcr Reagent

99. Bacteriostatic Water For Injection In Plastic Container

100. Sterile Water (tn)

101. Water, Lc/ms

102. Water, Endotoxin-free

103. Water With Tfa, Tfa

104. An Unknown Oxygen Source

105. Water [vandf]

106. Water, Optima Uhplcms

107. Water, Purified (usp)

108. H-oh

109. Water [inci]

110. Ddwater (endotoxin-free)

111. Purified Water (jp17)

112. Water (jp17/usp)

113. Water, For Toc Analysis

114. Aqua [inci]

115. Water [jan]

116. Water [who-dd]

117. Water [mi]

118. Distilled Water, For Hplc

119. Water, Deionized (<2us)

120. Water, Rnase, Dnase-free

121. 0.05% Tfa In Water

122. Pure Water Density Standard

123. Sterile Water For Injections

124. Water For Irrigation,sterile

125. Water, Hplc Gradient Grade

126. Water, Deionized (<10us)

127. Water, Demineralized, P.a.

128. Water,bacteriostatic Injection

129. Water For Injection (jp17)

130. Water, Distilled, Conductivity Or Of Similar Purity

131. Water, For Ion Chromatography

132. Water,reagent(deionizedwater)

133. B1217 [langual]

134. Hydrogen Oxide (h2o)

135. Density Standard 998 Kg/m3

136. Hydrofluoric Acid, 48-50%

137. Aqua Sterilisata Pro Injectione

138. Water, Ultrapure, Hplc Grade

139. Water, Bioperformance Certified

140. Purified Water [mart.]

141. Chembl1098659

142. Dtxsid6026296

143. Chebi:25805

144. Water, Molecular Biology Reagent

145. Xlyofnoqvpjjnp-uhfffaoysa-

146. Diethylpyrocarbonate-treated Water

147. Dtxsid00170378

148. Water, Reagent (deionized Water)

149. [oh2]

150. Water, Tested According To Ph.eur.

151. Nsc147337

152. Purified Water In Containers (jp17)

153. Akos015950726

154. E-toxate(tm) Water, Endotoxin, Free

155. Water With 0.1% Trifluoroacetic Acid

156. Db09145

157. Water With 0.05% Trifluoroacetic Acid

158. Water, For Uhplc, For Mass Spectrometry

159. Q283

160. Water For Injection In Containers (jp17)

161. Water, Ultrapure, Spectrophotometric Grade

162. Ft-0666297

163. Ft-0696358

164. Ft-0696590

165. Ft-0696628

166. Ft-0696641

167. Ft-0696971

168. Ft-0697004

169. Ft-0697144

170. Ft-0697158

171. Ft-0697170

172. Ft-0697209

173. Ft-0697243

174. Ft-0697253

175. Ft-0697259

176. Ft-0697294

177. Ft-0697297

178. Ft-0697301

179. Ft-0697341

180. Ft-0697349

181. Ft-0697357

182. Ft-0697405

183. Ft-0697446

184. Ft-0697449

185. Ft-0697507

186. Ft-0697572

187. Ft-0697623

188. Ft-0697627

189. Ft-0697628

190. Ft-0697674

191. Ft-0697714

192. Ft-0697757

193. Ft-0697788

194. Ft-0697792

195. Ft-0697796

196. Ft-0697843

197. Ft-0697856

198. Ft-0697866

199. Ft-0697871

200. Ft-0697889

201. Ft-0697898

202. Ft-0697905

203. Ft-0697910

204. Ft-0697922

205. Ft-0698010

206. Ft-0698017

207. Ft-0698043

208. Ft-0698101

209. Ft-0698115

210. Ft-0698166

211. Ft-0698169

212. Ft-0698223

213. Ft-0698239

214. Ft-0698270

215. Ft-0698271

216. Ft-0698321

217. Ft-0698348

218. Ft-0698364

219. Ft-0698424

220. Ft-0698457

221. Ft-0698465

222. Ft-0698477

223. Ft-0698494

224. Ft-0698589

225. Ft-0698592

226. Ft-0698708

227. Ft-0698717

228. Ft-0698718

229. Ft-0698751

230. Ft-0698783

231. Ft-0698819

232. Ft-0698821

233. Ft-0698831

234. Ft-0698832

235. Ft-0698834

236. Ft-0698835

237. Ft-0698842

238. Ft-0698843

239. Ft-0698847

240. Ft-0698849

241. Ft-0698856

242. Ft-0698897

243. Ft-0698914

244. Ft-0698990

245. Ft-0698992

246. Ft-0698993

247. Ft-0698996

248. Ft-0698999

249. Ft-0699000

250. Ft-0699001

251. Ft-0699002

252. Ft-0699003

253. Ft-0699004

254. Ft-0699005

255. Ft-0699007

256. Ft-0699017

257. Ft-0699037

258. Ft-0699049

259. Ft-0699053

260. Ft-0699078

261. Ft-0699128

262. Ft-0699173

263. Ft-0699177

264. Ft-0699181

265. Ft-0699195

266. Ft-0699197

267. Ft-0699222

268. Ft-0699237

269. Ft-0699244

270. Ft-0699257

271. Ft-0699263

272. Ft-0699270

273. Ft-0699281

274. Ft-0699301

275. Ft-0699381

276. Ft-0699391

277. Ft-0699491

278. Ft-0699565

279. Ft-0699582

280. Ft-0699656

281. Ft-0699660

282. Ft-0699667

283. Ft-0699668

284. Ft-0699680

285. Ft-0699707

286. Ft-0699726

287. Ft-0699727

288. Ft-0699728

289. Ft-0699749

290. Ft-0699751

291. Ft-0699763

292. Ft-0699780

293. Ft-0699822

294. Ft-0699826

295. Sterile Purified Water In Containers (jp17)

296. Water, Acs Reagent, For Ultratrace Analysis

297. Water With 0.1% Trifluoroacetic Acid (v/v)

298. Water, Packaged For Use In Deposition Systems

299. C00001

300. D00001

301. Water With 0.05% Trifluoroacetic Acid (v/v)

302. Water, Deuterium-depleted, 99.99995 Atom %

303. Q274959

304. Q427071

305. Water Solution, 0.005n In Sulfuric Acid, For Hplc

306. Water Solution, Contains 0.05 % (v/v) Acetic Acid

307. Water Solution, Contains 0.10 % (v/v) Acetic Acid

308. Water, Deuterium-depleted, <=1 Ppm (deuterium Oxide)

309. Water, For Hpce, For Luminescence, For Uv-spectroscopy

310. Density Standard 998 Kg/m3, H&d Fitzgerald Ltd. Quality

311. Water Solution, Contains 0.1 % (v/v) Ammonium Hydroxide

312. Water Solution, Contains 10 Mm Ammonium Acetate, For Hplc

313. Water Solution, Contains 0.05 % (v/v) Trifluoroacetic Acid

314. Water Solution, Contains 0.06 % (v/v) Trifluoroacetic Acid

315. Water Solution, For Hplc, Contains 0.1 % (v/v) Formic Acid

316. Water, For Molecular Biology, Depc-treated And Sterile Filtered

317. Water Solution, Hplc Grade, Contains 0.035 % (v/v) Acetic Acid

318. Water Solution, Contains 0.1 % (v/v) Trifluoroacetic Acid, For Hplc

319. Water, 99.999%, Contained In 50 Ml Swagelok? Cylinder For Cvd/ald

320. Water, Deionized 18 Megaohm Astm Type I, Suitable For Trace Metal Analysis

321. Water, For Cell Biology, Free Of Endotoxins, Ultrafiltered And Autoclaved

322. Water Solution, Contains 0.05 % (w/v) Ammonium Formate, 0.1 % (v/v) Formic Acid

323. Water Solution, Contains 0.1 % (v/v) Formic Acid, For Uhplc, For Mass Spectrometry

324. Water Solution, Contains 0.10 % (v/v) Formic Acid, 50.0 % (v/v) Acetonitrile

325. Water Solution, Contains 10.0 % (v/v) Methanol, 0.10 % (v/v) Trifluoroacetic Acid

326. Water Solution, Contains 20 % (v/v) Acetonitrile, 0.1 % (v/v) Formic Acid

327. Water, For Embryo Transfer, Sterile-filtered, Bioxtra, Suitable For Mouse Embryo

328. 8o

329. Oh2

2.4 Create Date
2004-09-16
3 Chemical and Physical Properties
Molecular Weight 18.015 g/mol
Molecular Formula H2O
XLogP3-0.5
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count1
Rotatable Bond Count0
Exact Mass18.010564683 g/mol
Monoisotopic Mass18.010564683 g/mol
Topological Polar Surface Area1 Ų
Heavy Atom Count1
Formal Charge0
Complexity0
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameBacteriostatic water for injection in plastic container
Drug LabelSterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent suitable for intravascular injection...
Active IngredientSterile water for injection
Dosage FormLiquid
RouteN/a
Strength100%
Market StatusPrescription
CompanyHospira

2 of 8  
Drug NameSterile water
Active IngredientSterile water for irrigation; Sterile water
Dosage FormInjectable; Liquid
Routeinjection; Irrigation
Strength100%; 10ml
Market StatusPrescription
CompanyBaxter Hlthcare; Taro Pharms Ireland

3 of 8  
Drug NameSterile water for injection in plastic container
Active IngredientSterile water for injection
Dosage FormLiquid
RouteN/a
Strength100%
Market StatusPrescription
CompanyHospira; Baxter Hlthcare; Fresenius Kabi Usa; B Braun; Taro Pharms Ireland

4 of 8  
Drug NameSterile water in plastic container
Active IngredientSterile water for irrigation
Dosage FormLiquid
RouteIrrigation
Strength100%
Market StatusPrescription
CompanyHospira; Baxter Hlthcare; B Braun

5 of 8  
Drug NameBacteriostatic water for injection in plastic container
Drug LabelSterile Water for Injection USP is a clear, colorless, odorless liquid. It is sterile, hypotonic, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Sterile Water for Injection USP is a diluent suitable for intravascular injection...
Active IngredientSterile water for injection
Dosage FormLiquid
RouteN/a
Strength100%
Market StatusPrescription
CompanyHospira

6 of 8  
Drug NameSterile water
Active IngredientSterile water for irrigation; Sterile water
Dosage FormInjectable; Liquid
Routeinjection; Irrigation
Strength100%; 10ml
Market StatusPrescription
CompanyBaxter Hlthcare; Taro Pharms Ireland

7 of 8  
Drug NameSterile water for injection in plastic container
Active IngredientSterile water for injection
Dosage FormLiquid
RouteN/a
Strength100%
Market StatusPrescription
CompanyHospira; Baxter Hlthcare; Fresenius Kabi Usa; B Braun; Taro Pharms Ireland

8 of 8  
Drug NameSterile water in plastic container
Active IngredientSterile water for irrigation
Dosage FormLiquid
RouteIrrigation
Strength100%
Market StatusPrescription
CompanyHospira; Baxter Hlthcare; B Braun

4.2 Drug Indication

For diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.


FDA Label


5 Pharmacology and Biochemistry
5.1 Absorption, Distribution and Excretion

Tritium radioactivity in mouse fetus taken from the pregnant female mouse which had been given tritium containing drinking water was measured to estimate the absorbed radiation dose from the incorporated tritium. BC3F1 female mice mated with ICR male were given drinking water containing various concentrations of tritium for whole pregnant period, from the morning when the vaginal plug was observed to the day just before term. At various times of the pregnant period, blood and fetuses were taken from the female mice to measure the tritium concentration using a Packard model of sample oxidizer. The absorbed radiation dose of the fetus from the incorporated tritium was estimated on the basis of the tritium concentration measured. The tritium concentration of the embryos increased gradually from the first pregnant day to reach the plateau level at the 7 to 9th day. The estimated radiation dose increased almost linearly depending on the tritium concentration in the drinking water. /Tritium containing drinking water/

Yamada T et al; J Radiat Res (Tokyo) 32 (1): 91 (1991)


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AP","supplier":"UBERONE LLC","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"OPTIMUS DRUGS PRIVATE LTD","customerCountry":"INDIA","quantity":"2500.00","actualQuantity":"2500","unit":"KGS","unitRateFc":"74","totalValueFC":"187305.5","currency":"USD","unitRateINR":"6800.6","date":"25-Feb-2026","totalValueINR":"17001500","totalValueInUsd":"187305.5","indian_port":"Madras Sea","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"7001 CORPORATE DR STE 100, HOUSTON, TX,77036 SDNF US","customerAddress":"PLOT NO.131,3RD FLOOR,NARMADA"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1772044200,"product":"((1,3-DIOXOLAN-2-YL)METHYL)TRIPHENYLPHOSPHONIUM BROMIDE - CS -W008414 - 52509-14-5","address":"102\/12 KRISHNA GREENLAND PARK,KASA","city":"THANE,MAHARASHTRA","supplier":"SHANGHAI KAIXIN PHARMACEUTICALS CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"JINAY PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3000","unit":"GMS","unitRateFc":"0.1","totalValueFC":"161.3","currency":"USD","unitRateINR":"4.9","date":"26-Feb-2026","totalValueINR":"14639.67","totalValueInUsd":"161.3","indian_port":"Bombay Air","hs_no":"29089990","bill_no":"5317","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":", LTD. ROOM 502,5\/F, NO.2 BUILDING, 720, CAILUN ROAD, ZHANGJIANG HIGH-TECH PARK SHANGHAI CHINA","customerAddress":"102\/12 KRISHNA GREENLAND PARK,KASA"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1772130600,"product":"326870010,N,N-DIMETHYLFORMAMIDE, 99.8%, WATER <50 PPM, EXTRA DRY, ACROSEAL(R)","address":"403-404, B WING, DELPHI,,HIRANANDA","city":"MUMBAI,MAHARASHTRA","supplier":"ACROS ORGANICS BVBA","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"THERMO FISHER SCIENTIFIC INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"LTR","unitRateFc":"62","totalValueFC":"942.1","currency":"USD","unitRateINR":"5701","date":"27-Feb-2026","totalValueINR":"85515.17","totalValueInUsd":"942.1","indian_port":"Hyderabad Air","hs_no":"29241990","bill_no":"231","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"ENA23,ZONE1,NR 1350 JANSSEN PHAR MACEUTICALAAN 3A B-2440 GEEL BTW\/VAT-no:BE0451.781.854-RPR Turnh BELGIUM","customerAddress":"403-404, B WING, DELPHI,,HIRANANDA"}]
03-Jan-2022
28-Feb-2026
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DOSAGE - LIQUID;IRRIGATION - 100%

USFDA APPLICATION NUMBER - 17428

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DOSAGE - LIQUID;N/A - 100%

USFDA APPLICATION NUMBER - 18233

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DOSAGE - LIQUID;N/A - 100% (100ML)

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100% (10ML)

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100% (1ML) **Federal Re...DOSAGE - LIQUID;N/A - 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100% (20ML)

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100% (5.2ML)

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100% (50ML)

USFDA APPLICATION NUMBER - 18801

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DOSAGE - LIQUID;N/A - 100%

USFDA APPLICATION NUMBER - 18802

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DOSAGE - LIQUID;N/A - 100%

USFDA APPLICATION NUMBER - 19869

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ABOUT THIS PAGE

Looking for 7732-18-5 / Water API manufacturers, exporters & distributors?

Water manufacturers, exporters & distributors 1

23

PharmaCompass offers a list of Water API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Water manufacturer or Water supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Water manufacturer or Water supplier.

PharmaCompass also assists you with knowing the Water API Price utilized in the formulation of products. Water API Price is not always fixed or binding as the Water Price is obtained through a variety of data sources. The Water Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Water

Synonyms

7732-18-5, Distilled water, Dihydrogen oxide, Sterile water, Purified water, Water vapor

Cas Number

7732-18-5

Unique Ingredient Identifier (UNII)

059QF0KO0R

About Water

A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

Ice Manufacturers

A Ice manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ice, including repackagers and relabelers. The FDA regulates Ice manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ice API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Ice manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ice Suppliers

A Ice supplier is an individual or a company that provides Ice active pharmaceutical ingredient (API) or Ice finished formulations upon request. The Ice suppliers may include Ice API manufacturers, exporters, distributors and traders.

click here to find a list of Ice suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ice USDMF

A Ice DMF (Drug Master File) is a document detailing the whole manufacturing process of Ice active pharmaceutical ingredient (API) in detail. Different forms of Ice DMFs exist exist since differing nations have different regulations, such as Ice USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ice DMF submitted to regulatory agencies in the US is known as a USDMF. Ice USDMF includes data on Ice's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ice USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ice suppliers with USDMF on PharmaCompass.

Ice CEP

A Ice CEP of the European Pharmacopoeia monograph is often referred to as a Ice Certificate of Suitability (COS). The purpose of a Ice CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ice EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ice to their clients by showing that a Ice CEP has been issued for it. The manufacturer submits a Ice CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ice CEP holder for the record. Additionally, the data presented in the Ice CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ice DMF.

A Ice CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ice CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Ice suppliers with CEP (COS) on PharmaCompass.

Ice GMP

Ice Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Ice GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ice GMP manufacturer or Ice GMP API supplier for your needs.

Ice CoA

A Ice CoA (Certificate of Analysis) is a formal document that attests to Ice's compliance with Ice specifications and serves as a tool for batch-level quality control.

Ice CoA mostly includes findings from lab analyses of a specific batch. For each Ice CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Ice may be tested according to a variety of international standards, such as European Pharmacopoeia (Ice EP), Ice JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ice USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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