Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
1. Anatase
2. Anatase Titanium Dioxide
3. Brookite
4. Food Additive E171
5. Nano-anatase
6. Nano-tio2
7. Rutile
8. Titania
9. Titanium Oxide
10. Titanium White
1. Rutile
2. 13463-67-7
3. Dioxotitanium
4. Anatase
5. Titania
6. Titanium(iv) Oxide
7. 1317-70-0
8. 1317-80-2
9. Titanium White
10. Anatase (tio2)
11. Flamenco
12. Hombitan
13. Titafrance
14. Titandioxid
15. Tiofine
16. Tioxide
17. Tipaque
18. Titanox
19. Rayox
20. Rutile (tio2)
21. Bayertitan A
22. Titanic Anhydride
23. Rutiox Cr
24. Tioxide Rhd
25. Tioxide Rsm
26. Titanox Ranc
27. Zopaque Ldc
28. A-fil Cream
29. Calcotone White T
30. Tioxide A-dm
31. Tioxide Ad-m
32. Tioxide R-cr
33. Tioxide R-sm
34. Tioxide R.xl
35. Bayertitan R-u-f
36. Levanox White Rkb
37. A-fil
38. Runa Rh20
39. Unitane Or-150
40. Unitane Or-340
41. Unitane Or-342
42. Unitane Or-350
43. Unitane Or-540
44. Unitane Or-640
45. Austiox R-cr 3
46. Cab-o-ti
47. Hombitan R 101d
48. Hombitan R 610k
49. Unitane O-110
50. Unitane O-220
51. Horse Head A-410
52. Horse Head A-420
53. Horse Head R-710
54. Kronos Rn 40p
55. Kronos Rn 56
56. Tipaque R 820
57. Titanox 2010
58. Unitane Or 450
59. Unitane Or 650
60. Kronos Cl 220
61. Kronos Titanium Dioxide
62. Kronos 2073
63. Runa Arh 20
64. Titanium Oxide (tio2)
65. 1700 White
66. P 25 (oxide)
67. C.i. Pigment White 6
68. Runa Arh 200
69. Ti-pure R 900
70. Ti-pure R 901
71. Titanium Peroxide (tio2)
72. Tiona T.d.
73. Atlas White Titanium Dioxide
74. Titanium(iv) Oxide, Rutile
75. C-weiss 7
76. Titanium(iv) Oxide, Anatase
77. Cosmetic White C47-5175
78. Cosmetic White C47-9623
79. Ro 2
80. Nci-c04240
81. Kh 360
82. Brookite
83. Tio2
84. C.i. 77891
85. E 171
86. R 680
87. Titanium Dioxide [usp]
88. Titanium Dioxide Enamel Grade
89. 98084-96-9
90. Mfcd00011269
91. Octahedrite
92. Tichlor
93. Unitane
94. Zopaque
95. Kronos
96. Tronox
97. Titanic Oxide
98. Titanium Dioxide (usp)
99. Bayertitan T
100. Tiona Td
101. Titan White
102. Anatase Titanium Dioxide
103. Tin Dioxide Dust
104. Titanium Peroxide
105. Uniwhite Ao
106. Uniwhite Ko
107. Trioxide(s)
108. Unitane Or
109. Pigment White 6
110. Ti-pure
111. Bayertitan An 3
112. Austiox R-cr
113. Tioxide A-hr
114. Tioxide R Xl
115. Bayertitan R-u 2
116. Bayertitan R-fk-d
117. Aerosil P 25
118. Aerosil P 27
119. Bayertitan R-fd 1
120. Bayertitan R-kb 2
121. Bayertitan R-kb 3
122. Bayertitan R-kb 4
123. Bayertitan R-kb 5
124. Bayertitan R-kb 6
125. Titandioxid (sweden)
126. Aerolyst 7710
127. Ci Pigment White 6
128. Uniwhite Or 450
129. Uniwhite Or 650
130. Tinoc M 6
131. Aerosil P 25s6
132. Aerosil T 805
133. Octahedrite (mineral)
134. Ak 15 (pigment)
135. Titandioxid [swedish]
136. Bayer R-fd 1
137. Blend White 9202
138. 63b1 White
139. Bayertitan
140. Bayertitan R-fk 21
141. Titanium Oxide (van)
142. A 200 (pigment)
143. A 330 (pigment)
144. Amperit 780.0
145. B 101 (pigment)
146. Baytitan
147. Kronos 1002
148. R 830 (mineral)
149. Unitane 0-110
150. Unitane 0-220
151. C-weiss 7 [german]
152. Mc 50 (oxide)
153. C 97 (oxide)
154. Cg-t
155. Nt 100 (oxide)
156. Mfcd00210650
157. Bayertitan R-v-se 20
158. S 150 (oxide)
159. Titanium(iv) Oxide, Catalyst Support
160. Bistrater L-nsc 200c
161. 15 Wt% Titanium Oxide In Water Nano
162. Ccris 590
163. A-fn 3
164. Hsdb 869
165. Nci-c0424o
166. Auf 0015s
167. Amt 100
168. Amt 600
169. Jr 600a
170. Rutile Titanium Dioxide
171. Cosmetic Hydrophobic Tio2 9428
172. 234da
173. 500hd
174. Cosmetic Micro Blend Tio2 9228
175. Einecs 215-280-1
176. Einecs 215-282-2
177. Einecs 236-675-5
178. Cl 310
179. Nsc 15204
180. Orgasol 1002d White 10 Extra Cos
181. Unii-15fix9v2jp
182. Titanium(iv) Oxide, Anatase Nanoparticles / Nanopowder
183. 1385rn 59
184. Ai3-01334
185. Br 29-7-2
186. Ccris 9317
187. Ccris 9325
188. Titanium-dioxide
189. Dioxyde De Titane
190. (rutile)
191. Bis(oxido)titanium
192. Dioxido De Titanio
193. Component Of A-fil
194. Oxido De Titanio(iv)
195. Titanium Oxide Anatase
196. Titanium Oxide, Tio2
197. Titanium Dioxide Rutile
198. Titanium( Cento) Oxide
199. Titania Paste, Reflector
200. Titanium Oxide (jp17)
201. Titanium Dioxide (tio2)
202. Titania Paste, Transparent
203. Wln: Ti O
204. Ec 215-282-2
205. Ec 236-675-5
206. [tio2]
207. Titania Paste, Active Opaque
208. Titanium(iv) Oxide Nanopowder
209. Titanium (iv) Oxide Anhydrous
210. Titanium(iv) Oxide, 1 Micron
211. Titanium(iv) Oxide, 98.0%
212. Chebi:32234
213. Titanium Dioxide (anatase)
214. Nsc15204
215. Titanium(iv) Oxide, Sintered Lumps
216. Nano Titanium Dioxide Anatase Powder
217. Akos015913799
218. Db09536
219. Titanium Dioxide-rutile Type Blr-699
220. Titanium(iv) Oxide, High Surface Area
221. Titanium Dioxide Anatase Type Bla-200
222. Ncgc00187590-01
223. Titanium Dioxide, Nist(r) Srm(r) 154c
224. Titanium(iv) Oxide, Rutile, Single Crystal
225. Cs-0031311
226. Ft-0645791
227. Ft-0778081
228. Titanium Oxide (anatase) Powder, 99% Nano
229. D01931
230. T-3875
231. Titanium(iv) Oxide, Reagentplus(r), >=99%
232. Q193521
233. Titanium(iv) Oxide, Saj First Grade, >=98.0%
234. J-006053
235. Titanium(iv) Oxide, Jis Special Grade, >=99.0%
236. Titanium(iv) Oxide, Vetec(tm) Reagent Grade, 99%
237. Titanium Dioxide, Nist(r) Srm(r) 1898, Nanomaterial
238. Titanium(iv) Oxide, 20-35% In H2o Colloidal Dispersion
239. Titanium(iv) Oxide, Rutile, >=99.98% Trace Metals Basis
240. Titanium(iv) Oxide, Rutile, 99.995% Trace Metals Basis
241. Titanium Dioxide (airborne, Unbound Particles Of Respirable Size
242. Titanium(iv) Oxide, Anatase, Powder, 99.8% Trace Metals Basis
243. Titanium(iv) Oxide, Nanowires, Diam. X L ~10 Nm X 10 Mum
244. Titanium(iv) Oxide, Nanowires, Diam. X L ~100 Nm X 10 Mum
245. Titanium Dioxide, Nist Rm 8988, Powder, Particle Size Distribution
246. Titanium(iv) Oxide, Pellets, Diam. X Thickness 12.5 Mm X 5.5 Mm
247. Titanium Dioxide, United States Pharmacopeia (usp) Reference Standard
248. Titanium Oxide Dispersion (anatase, 20 Wt%, 5-30 Nm) Nano In Water
249. Titanium(iv) Oxide, Anatase, Powder, -325 Mesh, >=99% Trace Metals Basis
250. Titanium(iv) Oxide, Rutile, Powder, <5 Mum, >=99.9% Trace Metals Basis
251. Titanium(iv) Oxide, Anatase, Nanopowder, <25 Nm Particle Size, 99.7% Trace Metals Basis
252. Titanium(iv) Oxide, Naturally Occurring Mineral, Grains, Approximately 0.06-0.19in
253. Titanium(iv) Oxide, Rutile, Nanopowder, <100 Nm Particle Size, 99.5% Trace Metals Basis
254. Titanium(iv) Oxide, Contains 1% Mn As Dopant, Nanopowder, <100 Nm Particle Size (bet), >=97%
255. Titanium(iv) Oxide, Mixture Of Rutile And Anatase, Nanoparticle, <250 Nm Particle Size (dls), Paste, 53-57 Wt. % In Diethylene Glycol Monobutyl Ether/ethylene Glycol, 99.9% Trace Metals Basis
256. Titanium(iv) Oxide, Mixture Of Rutile And Anatase, Nanoparticles, <100 Nm Particle Size, Dispersion, 48-52 Wt. % In Xylene, 99.9% Trace Metals Basis
257. Titanium(iv) Oxide, Mixture Of Rutile And Anatase, Nanoparticles, <150 Nm Particle Size (volume Distribution, Dls), Dispersion, 33-37 Wt. % In H2o, 99.5% Trace Metals Basis
258. Titanium(iv) Oxide, Mixture Of Rutile And Anatase, Nanopowder, <100 Nm Particle Size (bet), 99.5% Trace Metals Basis
259. Titanium(iv) Oxide, Nanopowder, 21 Nm Primary Particle Size (tem), >=99.5% Trace Metals Basis
260. Titanium(iv) Oxide, Puriss., Meets Analytical Specification Of Ph. Eur., Bp, Usp, 99-100.5%
261. Titanium(iv) Oxide, Rutile, <001>, (single Crystal Substrate), 99.99% Trace Metals Basis, L X W X Thickness 10 Mm X 10 Mm X 0.5 Mm
262. Titanium(iv) Oxide, Rutile, <100>, (single Crystal Substrate), 99.99% Trace Metals Basis, L X W X Thickness 10 Mm X 10 Mm X 0.5 Mm
263. Titanium(iv) Oxide, Rutile, <110>, Single Crystal Substrate, 99.99% Trace Metals Basis, L X W X Thickness 10 Mm X 10 Mm X 0.5 Mm
Molecular Weight | 79.866 g/mol |
---|---|
Molecular Formula | O2Ti |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 0 |
Exact Mass | 79.9377699 g/mol |
Monoisotopic Mass | 79.9377699 g/mol |
Topological Polar Surface Area | 34.1 Ų |
Heavy Atom Count | 3 |
Formal Charge | 0 |
Complexity | 18.3 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Photosensitizing Agents; Sunscreening Agents
National Library of Medicine's Medical Subject Headings online file (MeSH, 2013)
Titanium dioxide has an action on the skin similar to that of zinc oxide and has similar uses. Titanium peroxide and titanium salicylate are used with titanium dioxide for nappy rash. Titanium dioxide reflects ultraviolet light and is used a physical sunscreen. It it also an ingredient of some cosmetics.
SWEETMAN, S.C. (ed.) Martindale-The Complete Drug Reference. 36th ed. London: The Pharmaceutical Press, 2009., p. 1618
The physical compounds titanium dioxide and zinc oxide reflect, scatter, and absorb both UVA and UVB rays. ... Using new technology, the particle sizes of zinc oxide and titanium dioxide have been reduced, making them more transparent without losing their ability to screen UV.
US EPA; Sunscreens: The Burning Facts p.4 EPA 430-F-06-013 (September 2006). Available from, as of November 5, 2013: https://www.epa.gov/sunwise/doc/sunscreen.pdf
The manufacturers of sunscreen preparations with propellants warn that concentrating and subsequently inhaling the fumes from these preparations may be harmful or fatal. /Propellants/
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013
Because the absorptive characteristics of skin of children younger than 6 months of age may differ from those of adults and because the immaturity of metabolic and excretory pathways of these children may limit their ability to eliminate any percutaneously absorbed sunscreen agent, sunscreen products should be used in children younger than 6 months of age only as directed by a clinician. It is possible that the characteristics of geriatric skin also differ from those of skin in younger adults, but these characteristics and the need for special considerations regarding use of sunscreen preparations in this age group are poorly understood. /Sunscreens/
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013
Little information is available regarding the safety of chronic sunscreen usage, but commercially available physical and chemical sunscreens appear to have a low incidence of adverse effects. Derivatives of PABA, benzophenone, cinnamic acid, and salicylate and 2-phenylbenzimidazole-5-sulfonic acid have caused skin irritation including burning, stinging, pruritus, and erythema on rare occasions. /Sunscreens/
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013
Sunscreens should not be used as a means of extending the duration of solar exposure, such as prolonging sunbathing, and should not be used as a substitute for clothing on usually unexposed sites, such as the trunk and buttocks. /Sunscreens/
IARC Working Group on the Evaluation of Cancer-Preventive Agents (2001) Sunscreens (IARC Handbooks of Cancer Prevention, Vol. 5), Lyon, IARC; Unit of Chemoprevention: Cancer-Preventive Effects of Sunscreens.
For more Drug Warnings (Complete) data for TITANIUM DIOXIDE (11 total), please visit the HSDB record page.
Titanium dioxide is used in most sunscreens to block UVA and UVB rays, similar to [zinc oxide].
Photosensitizing Agents
Drugs that are pharmacologically inactive but when exposed to ultraviolet radiation or sunlight are converted to their active metabolite to produce a beneficial reaction affecting the diseased tissue. These compounds can be administered topically or systemically and have been used therapeutically to treat psoriasis and various types of neoplasms. (See all compounds classified as Photosensitizing Agents.)
Coloring Agents
Chemicals and substances that impart color including soluble dyes and insoluble pigments. They are used in INKS; PAINTS; and as INDICATORS AND REAGENTS. (See all compounds classified as Coloring Agents.)
Sunscreening Agents
Chemical or physical agents that protect the skin from sunburn and erythema by absorbing or blocking ultraviolet radiation. (See all compounds classified as Sunscreening Agents.)
Biocompatible Materials
Synthetic or natural materials, other than DRUGS, that are used to replace or repair any body TISSUES or bodily function. (See all compounds classified as Biocompatible Materials.)
Absorption
When male and female rats were fed a diet containing titanium dioxide (100 g/kg) for a period of about 32 days, a significant retention of titanium of 0.06 and 0.11 mg/kg wet weight was found only in the muscles; no retention was observed in the liver, spleen, kidney, bone, plasma, or erythrocytes
Route of Elimination
The kinetics of TiO2 elimination in the rat lung following its deposition after 7 hr exposure at 10 and 50 mg/cu m were determined for periods up to 140 days.The retention half-time was 14 days for the first clearance phase and 88 days thereafter.
Volume of Distribution
Six hours after titanium dioxide was administered to rats through IV injection at 250 mg/kg body weight, the highest concentration appeared in the liver; after 24 hours, the highest concentration was detected in the celiac lymph nodes, which filter the lymph from the liver.
Clearance
The clearance of titanium dioxide from the lungs was studied in rats after inhalation of 15 or 100 mg/cu m. The average median aerodynamic diameter of the titanium dioxide particles was 1.48 um. After a single exposure, about 40-45% of the deposited particles were cleared from the lung in 25 days. At 15 mg/cu m, 0.7% was found in the hilar lymph nodes indicating penetration of titanium dioxide particles from alveoli into the lymphatic system and partial clearance by the lymphatic route. The clearance rate was similar after intra-tracheal administration of titanium dioxide. At an exposure of 100 mg/cu m, the clearance rate decreased drastically. /Other researchers/ demonstrated the presence of titanium dioxide in the lymphatic systems of 3 workers employed in processing titanium dioxide pigments.
The deposition of titanium dioxide dust in the lungs of rats is similar to that observed for other particles. Titanium dioxide is found in the lymphocytes and regional nodes in the lungs, indicating that a slow rate of removal occurs by this process. Clearance is also significantly decreased, or even ceases, at high exposure over a period of time because of overload. It is suggested that small amounts of titanium dioxide can enter the general circulation from the lungs.
Norderg, G.F. et al; Handbook on the Toxicology of Metals 3rd ed. Academic Press, Burlington, MA. 2007, p. 864
The case of a 53-year-old man with pneumoconiosis due to approximately 13 years of occupational exposure to 'high' concentrations of titanium dioxide /is reported/. The patient died of lung cancer, which was possibly associated with a 34 pack-year smoking history and not attributed to exposure to titanium dioxide. At autopsy, about 9-10 years after the exposures to titanium dioxide, particle deposition was found to be diffuse in the lung and particles were typically found in interstitial and alveolar macrophages. Examination of lung tissue in the right upper lobe and right hilar lymph nodes showed deposits of crystalloid substances that had a high titanium content and measured 0.2-0.3 um by 0.7 um.
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V93 232 (2010)
Six hours after titanium dioxide was administered to rats through IV injection at 250 mg/kg body weight, the highest concentration appeared in the liver; after 24 hours, the highest concentration was detected in the celiac lymph nodes, which filter the lymph from the liver.
Norderg, G.F. et al; Handbook on the Toxicology of Metals 3rd ed. Academic Press, Burlington, MA. 2007, p. 864
/Researchers/ studied lung specimens from three factory workers exposed for 9 years to the processing of titanium dioxide pigments; they found deposits in the pulmonary interstitium with cell destruction and slight fibrosis. Clearance of titanium dioxide through the lymphatic system was demonstrated by the observation of particles in the lymph nodes.
Norderg, G.F. et al; Handbook on the Toxicology of Metals 3rd ed. Academic Press, Burlington, MA. 2007, p. 866
For more Absorption, Distribution and Excretion (Complete) data for TITANIUM DIOXIDE (13 total), please visit the HSDB record page.
Rats were intraperitoneal injected with 1.60 g/100 g body wt of TiO(2) in saline solution. Organs (liver, spleen, lung) were processed for histological evaluation. Reactive oxygen species (ROS) in alveolar macrophages obtained by bronchoalveolar lavage (BAL) were evaluated using the nitroblue tetrazolium test and quantitative evaluation by digital image analysis. The histological analysis of organs revealed the presence of titanium in the parenchyma of these organs with no associated tissue damage. Although in lung alveolar macrophages TiO(2) induced a significant rise in ROS generation, it failed to cause tissue alteration. This finding may be attributed to an adaptive response.
The kinetics of TiO2 elimination in the rat lung following its deposition after 7 hr exposure at 10 and 50 mg/cu m were determined for periods up to 140 days...The retention half-time was 14 days for the first clearance phase and 88 days thereafter.
The kinetics of TiO2 elimination in the rat lung following its deposition after 7 hr exposure at 10 and 50 mg/cu m were determined for periods up to 140 days...The retention half-time was 14 days for the first clearance phase and 88 days thereafter.
Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 2:686
Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent.
Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. /Sunscreen agents, topical/
Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12195
Submission : 1996-10-31
Status : Inactive
Type : II
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
About the Company : Brenntag is the global market leader in providing a full range of chemicals and ingredients and value-added services. By connecting chemical manufacturers (our suppliers) and chemi...
About the Company : Nitika Pharmaceutical Specialities was found in 1991 as a small manufacturing unit has grown today into a dynamic production center for a range of products finding applications in ...
Related Excipient Companies
Dosage Form : Capsule
Grade : Oral, Topical
Dosage Form : Powder
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral, Topical
Application : Disintegrants & Superdisintegrants
Excipient Details : Glycine is used as a disintegrant in solid dosage forms such as orally disintegrating tablets and in topical formulations such as emulsions & creams.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 75.07 g/mol
Ingredient(s) : Glycine Excipient
Dosage Form : Gel
Grade : Topical
Application : Topical
Excipient Details : L-Alanine is used in topical semi-solid dosage forms such as creams, lotions, ointments, gels, etc.
Dosage Form : Capsule
Grade : Oral
Application : Taste Masking
Excipient Details : L-Leucine is used as a lubricating and taste masking agent in oral solids such as tablets and capsules.
Dosage Form : Shampoo
Grade : Topical
Application : Topical
Excipient Details : L-Lysine HCl is used in semi-solid dosage forms such as creams, lotions, shampoos, etc.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 182.7 g/mol
Ingredient(s) : L Lysine HCl Excipient
Dosage Form : Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : L-methionine is used as a solubility enhancer to improve the solubility of poorly soluble drugs such as tablets.
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Dosage Form : Gel
Grade : Topical
Application : Topical
Excipient Details : L-Serine is used in topical semi-solid formulations such as creams, lotions and gel.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 105.1 g/mol
Ingredient(s) : L Serine Excipient
Dosage Form : Gel
Grade : Topical
Application : Topical
Excipient Details : L-Threonine is used in semi-solid topical formulations such as lotion, cream, gel and ointment.
Pharmacopoeia Ref : NA
Technical Specs : Molecular weight: 119.1 g/mol
Ingredient(s) : L-Threonine Excipient
Dosage Form : Syrup
Grade : Oral
Dosage Form : Tablet
Grade : Topical, Oral
Dosage Form : Syrup
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Topical
Application : Thickeners and Stabilizers
Excipient Details : Pectin is used as a thickening and stabilizing agent in the production of pharmaceutical suspensions and creams.
Dosage Form : Tablet
Grade : Oral
Dosage Form : Suspension
Grade : Oral
Dosage Form : Solution
Grade : Oral
Application : Thickeners and Stabilizers
Excipient Details : Tapioca is used as a thickening agent and stabilizer in pharmaceutical liquid dosage form production.
Dosage Form : Syrup
Grade : Oral
Dosage Form : Capsule
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : AHMC 0600 is a co-processed aluminum hydroxide and magnesium carbonate powder used in immediate-relief antacid tablet formulation.
Pharmacopoeia Ref : NA
Technical Specs : Apparent Density: 0.30-0.40
Ingredient(s) : Aluminum Hydroxide Excipient
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : AHMC 0611 is a co-processed aluminum hydroxide & magnesium carbonate micronized powder used in immediate-relief antacid tablets & liquid suspensions.
Pharmacopoeia Ref : NA
Technical Specs : Tapped NMT: 0.2
Ingredient(s) : Aluminum Hydroxide Excipient
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CM90 is a directly compressible, granulated calcium carbonate with maltodextrin used for swallow tablets due to its high density and compressibility.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 490- 500, Tapped Density: 1.50
Ingredient(s) : Calcium Carbonate Excipient
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : DC SIM 100 is a directly compressible simethicone powder used for antacid and anti-gas tablets.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
Ingredient(s) : Starch
Dosage Form : Gel
Grade : Oral
Application : Thickeners and Stabilizers
Excipient Details : SPI® VAC Gels are based on highly engineered pseudo-boehmite and are used as vaccine adjuvants.
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Topical
Application : Surfactant & Foaming Agents
Excipient Details : Vitamin E TPGS, a multirole excipient, acts as a surfactant in various oral and topical dosage forms.
Dosage Form : Cream / Lotion / Ointment
Grade : Oral, Topical
Application : Topical
Excipient Details : Capmul 808G is used in topical formulations and as a surfactant in creams, lotions, and solutions.
Pharmacopoeia Ref : EP, USP/NF
Technical Specs : N/A
Ingredient(s) : Glyceryl Monocaprylate Excipient
Dosage Form : Tablet
Grade : Parenteral, Oral, Topical
Application : Fillers, Diluents & Binders
Excipient Details : Captex 300 is used in parenteral solutions and suspensions, topical emulsions, and as filler and lubricant in capsules and tablets.
Pharmacopoeia Ref : EP, USP/NF, JP, US FDA
Technical Specs : LOW C6
Ingredient(s) : Glyceryl Tricaprylate Excipient
Dosage Form : Tablet
Grade : Oral, Topical
Application : Lubricants & Glidants
Excipient Details : Captex 355 is used in topical emulsions and as a lubricant and filler in capsules and tablets.
Pharmacopoeia Ref : EP, USP/NF, JP, US FDA
Technical Specs : N/A
Ingredient(s) : Glyceryl Tricaprylate Excipient
Dosage Form : Tablet
Grade : Parenteral, Oral, Topical
Application : Fillers, Diluents & Binders
Excipient Details : Captex 8000 is used in parenteral solutions and suspensions, topical emulsions, and as filler and lubricant in capsules and tablets.
Pharmacopoeia Ref : JP, US FDA
Technical Specs : N/A
Ingredient(s) : Glyceryl Tricaprylate Excipient
Dosage Form : Syrup
Grade : Oral
Dosage Form : Tablet
Grade : Oral, Topical
Application : Taste Masking
Excipient Details : Cocoa chocolate flavour AR0879 is used in topical formulations including creams, lotions & sprays, and as a taste masking agent in tablets and syrups.
Pharmacopoeia Ref : GMP, Kosher, Halal, Non-GMO, B...
Technical Specs : Recommended Dosage: 0.2-0.3%
Ingredient(s) : Cocoa
Dosage Form : Ophthalmic Solution
Grade : Parenteral
Application : Solubilizers
Excipient Details : Dextran 40 is used as a solubilizer in parenteral formulations such as ophthalmic solutions and injections.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Insoluble saccharin (Q-0350, 15-191201) is used as an artificial sweetener in syrups, liquids, suspensions, mouthwashes, and tablets.
Pharmacopoeia Ref : USP/NF, JP, Kosher, ISO, Halal...
Technical Specs : Min. 98% Purity
Ingredient(s) : Saccharinum
Dosage Form : Tablet
Grade : Oral
Excipients by Applications
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Titanium Dioxide API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Titanium Dioxide API, including repackagers and relabelers. The FDA regulates Titanium Dioxide API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Titanium Dioxide API 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 Titanium Dioxide API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Titanium Dioxide API supplier is an individual or a company that provides Titanium Dioxide API active pharmaceutical ingredient (API) or Titanium Dioxide API finished formulations upon request. The Titanium Dioxide API suppliers may include Titanium Dioxide API API manufacturers, exporters, distributors and traders.
click here to find a list of Titanium Dioxide API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Titanium Dioxide API DMF (Drug Master File) is a document detailing the whole manufacturing process of Titanium Dioxide API active pharmaceutical ingredient (API) in detail. Different forms of Titanium Dioxide API DMFs exist exist since differing nations have different regulations, such as Titanium Dioxide API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Titanium Dioxide API DMF submitted to regulatory agencies in the US is known as a USDMF. Titanium Dioxide API USDMF includes data on Titanium Dioxide API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Titanium Dioxide API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Titanium Dioxide API suppliers with USDMF on PharmaCompass.
Titanium Dioxide API 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 Titanium Dioxide API 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 Titanium Dioxide API GMP manufacturer or Titanium Dioxide API GMP API supplier for your needs.
A Titanium Dioxide API CoA (Certificate of Analysis) is a formal document that attests to Titanium Dioxide API's compliance with Titanium Dioxide API specifications and serves as a tool for batch-level quality control.
Titanium Dioxide API CoA mostly includes findings from lab analyses of a specific batch. For each Titanium Dioxide API 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.
Titanium Dioxide API may be tested according to a variety of international standards, such as European Pharmacopoeia (Titanium Dioxide API EP), Titanium Dioxide API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Titanium Dioxide API USP).
LOOKING FOR A SUPPLIER?