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Pentobarbital Sodium

Suanfarma Pentobarbital Sodium

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Suanfarma Pentobarbital Sodium

Synopsis

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Chemistry

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Also known as: Pentobarbitone, Nembutal, Mebubarbital, Mebumal, Ethaminal, Pentobarbituric acid

Molecular Formula

C₁₁H₁₈N₂O₃

Molecular Weight

226.27 g/mol

InChI Key

WEXRUCMBJFQVBZ-UHFFFAOYSA-N

FDA UNII

I4744080IR

Pentobarbital Sodium

A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236)

1 2D Structure

Pentobarbital Sodium

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-ethyl-5-pentan-2-yl-1,3-diazinane-2,4,6-trione

2.1.2 InChI

InChI=1S/C11H18N2O3/c1-4-6-7(3)11(5-2)8(14)12-10(16)13-9(11)15/h7H,4-6H2,1-3H3,(H2,12,13,14,15,16)

2.1.3 InChI Key

WEXRUCMBJFQVBZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CCCC(C)C1(C(=O)NC(=O)NC1=O)CC

2.2 Other Identifiers

2.2.1 UNII

I4744080IR

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Diabutal

2. Etaminal

3. Ethaminal

4. Mebubarbital

5. Mebumal

6. Monosodium Salt Pentobarbital

7. Nembutal

8. Pentobarbital Sodium

9. Pentobarbital, Monosodium Salt

10. Pentobarbitone

11. Sagatal

2.3.2 Depositor-Supplied Synonyms

1. Pentobarbitone

2. Nembutal

3. Mebubarbital

4. Mebumal

5. Ethaminal

6. Pentobarbituric Acid

7. Neodorm

8. 76-74-4

9. Dorsital

10. Nebralin

11. Rivadorm

12. Pentobarbiturate

13. Pentabarbitone

14. Neodorm (new)

15. Pentabarbital

16. Pentobarbitalum

17. 5-ethyl-5-(sec-pentyl)barbituric Acid

18. 5-ethyl-5-(1-methylbutyl)barbituric Acid

19. 5-ethyl-5-(1-methylbutyl)malonylurea

20. 5-ethyl-5-(1-methylbutyl)-2,4,6(1h,3h,5h)-pyrimidinetrione

21. 2,4,6(1h,3h,5h)-pyrimidinetrione, 5-ethyl-5-(1-methylbutyl)-

22. Nsc 28708

23. Sodium Pentobarbital

24. Pentobarbital Cii

25. Pentobarbital Calcium

26. Barbituric Acid, 5-ethyl-5-(1-methylbutyl)-

27. Nsc-28708

28. 5-ethyl-5-(pentan-2-yl)pyrimidine-2,4,6(1h,3h,5h)-trione

29. Chembl448

30. 5-ethyl-5-pentan-2-yl-1,3-diazinane-2,4,6-trione

31. Chebi:7983

32. Aethaminalum

33. I4744080ir

34. Nembutal (van)

35. Neodorm (van)

36. Ncgc00096074-01

37. Pentobarbitale

38. Pentobarbital (van)

39. Pentobarbitone (van)

40. Pentobarbitale [dcit]

41. 5-ethyl-5-(1-methyl-butyl)-pyrimidine-2,4,6-trione

42. Pentobarbitalum [inn-latin]

43. 5-ethyl-5-(pentan-2-yl)-1,3-diazinane-2,4,6-trione

44. Phetobarbitone

45. 5-ethyl-2-hydroxy-5-(1-methylbutyl)pyrimidine-4,6(1h,5h)-dione

46. Nembutal (tn)

47. Ethyl-propylmethylcarbinylbarbituric Acid

48. Ccris 7089

49. Pentobarbital [inn]

50. Hsdb 3151

51. Einecs 200-983-8

52. Pentobarbital (usp/inn)

53. Brn 0087067

54. Barbituric Acid, 5-ethyl-5-(2-pentyl)-

55. Pentobarbital [usp:inn:ban]

56. Sr-01000317092

57. Unii-i4744080ir

58. (+-)-5-ethyl-5-(1-methylbutyl)barbituric Acid

59. (rs)-pentobarbital

60. Continal (salt/mix)

61. (plusmn)-pentobarbital

62. Sedalixir (salt/mix)

63. Spectrum_001783

64. 57-33-0

65. Spectrum2_001991

66. Spectrum3_001783

67. Spectrum4_000574

68. Spectrum5_001705

69. Dsstox_cid_3435

70. Pentobarbital [mi]

71. Ec 200-983-8

72. (.+/-.))-pentobarbital

73. Dsstox_rid_77026

74. Pentobarbital [hsdb]

75. Dsstox_gsid_23435

76. Oprea1_143902

77. Oprea1_775730

78. Schembl24966

79. Bspbio_003305

80. Kbiogr_001008

81. Kbioss_002267

82. Pentobarbital [vandf]

83. 5-24-09-00168 (beilstein Handbook Reference)

84. Divk1c_000992

85. Pentobarbital [mart.]

86. Spectrum1900006

87. Spbio_002201

88. Pentobarbital [who-dd]

89. Gtpl5480

90. Dtxsid7023435

91. Schembl11114711

92. Component Of Emesert (salt/mix)

93. Component Of Synirin (salt/mix)

94. Hms503g05

95. Kbio1_000992

96. Kbio2_002266

97. Kbio2_004834

98. Kbio2_007402

99. Kbio3_002807

100. Ninds_000992

101. Hms2094e21

102. Hms3713b10

103. Pentobarbital [green Book]

104. Pharmakon1600-01900006

105. Pentobarbital [orange Book]

106. Pentobarbital Cii [usp-rs]

107. Nsc28708

108. Pentobarbital [ep Monograph]

109. Tox21_111555

110. Bdbm50055935

111. Ccg-39476

112. Nsc760434

113. Pentobarbital [usp Monograph]

114. Stl367899

115. Pentobarbital 0.1 Mg/ml In Methanol

116. Pentobarbital 1.0 Mg/ml In Methanol

117. 2,4,6(1h,3h,5h)-pyrimidinetrione, 5-ethyl-5-(1-methylbutyl)-, (+-)-

118. Akos000277861

119. Wln: T6vmvmv Fhj Fy3&1 F2

120. Ccg-220564

121. Db00312

122. Nsc-760434

123. Cas-76-74-4

124. Idi1_000992

125. Ncgc00096074-02

126. Ncgc00344563-01

127. Sbi-0052713.p002

128. Db-056119

129. C07422

130. D00499

131. 057p561

132. Q409632

133. Sr-05000001789

134. Thiopental Sodium Impurity B [ep Impurity]

135. Sr-01000317092-2

136. Sr-05000001789-1

137. Brd-a44448661-001-01-4

138. (+/-)-5-ethyl-5-(1-methylbutyl)barbituric Acid

139. 2,6(1h,3h,5h)-pyrimidinetrione, 5-ethyl-5-(1-methylbutyl)-

140. 5-ethyl-5-(1-methylbutyl)-2,6(1h,3h,5h)-pyrimidinetrione

141. Pentobarbital, European Pharmacopoeia (ep) Reference Standard

142. Pentobarbital, United States Pharmacopeia (usp) Reference Standard

143. 2,4,6(1h,3h,5h)-pyrimidinetrione, 5-ethyl-5-(1-methylbutyl)-, (+/-)-

144. Pentobarbital Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

2.4 Create Date

2005-03-25

3 Chemical and Physical Properties

Molecular Formula	C₁₁H₁₈N₂O₃
Molecular Weight	226.27 g/mol
XLogP3	2.1
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	4
Exact Mass	226.13174244 g/mol
Monoisotopic Mass	226.13174244 g/mol
Topological Polar Surface Area	75.3 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	305
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Nembutal sodium
Drug Label	The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Contro...
Active Ingredient	Pentobarbital sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Oak Pharms

2 of 2
Drug Name	Nembutal sodium
Drug Label	The barbiturates are nonselective central nervous system depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their sodium salts are subject to control under the Federal Contro...
Active Ingredient	Pentobarbital sodium
Dosage Form	Injectable
Route	Injection
Strength	50mg/ml
Market Status	Prescription
Company	Oak Pharms

4.2 Therapeutic Uses

Adjuvants, Anesthesia; GABA Modulators; Sedatives, Barbiturate

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

/Pentobarbital sodium is indicated for use as a/ sedative. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

/Pentobarbital sodium is indicated for use as a/ hypnotic, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

/Pentobarbital sodium is indicated for use as a/ preanesthetic. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (Pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

For more Therapeutic Uses (Complete) data for Pentobarbital (10 total), please visit the HSDB record page.

4.3 Drug Warning

Barbiturates may be habit forming. Tolerance, psychological and physical dependence may occur with continued use. Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive dosage over long periods of time.

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

Nembutal Sodium capsules contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

IV administered pentobarbital sodium may cause respiratory depression, apnea, laryngospasm, bronchospasm, or hypotension, particularly if the drug is administered too rapidly. When administered IV, the drug must be administered slowly, and personnel and equipment should be readily available for administration of artificial respiration. Too rapid administration may cause respiratory depression, apnea, laryngospasm, or vasodilation with fall in blood pressure.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse.

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

For more Drug Warnings (Complete) data for Pentobarbital (34 total), please visit the HSDB record page.

4.4 Minimum/Potential Fatal Human Dose

The toxic dose of barbiturates varies considerably but, in general, a severe reaction is likely to occur when the amount ingested is more than 10 times the usual oral hypnotic dose. Potentially lethal blood concentrations are those in excess of 80 ug/mL for phenobarbital, 50 ug/mL for amobarbital or butabarbital, and approximately 30 ug/mL for secobarbital or pentobarbital; however, some patients have survived much higher blood concentrations. /Barbiturates General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2578

4.5 Drug Indication

For the short-term treatment of insomnia.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Pentobarbital, a barbiturate, is used for the treatment of short term insomnia. It belongs to a group of medicines called central nervous system (CNS) depressants that induce drowsiness and relieve tension or nervousness. Little analgesia is conferred by barbiturates; their use in the presence of pain may result in excitation.

5.2 MeSH Pharmacological Classification

GABA Modulators

Substances that do not act as agonists or antagonists but do affect the GAMMA-AMINOBUTYRIC ACID receptor-ionophore complex. GABA-A receptors (RECEPTORS, GABA-A) appear to have at least three allosteric sites at which modulators act: a site at which BENZODIAZEPINES act by increasing the opening frequency of GAMMA-AMINOBUTYRIC ACID-activated chloride channels; a site at which BARBITURATES act to prolong the duration of channel opening; and a site at which some steroids may act. GENERAL ANESTHETICS probably act at least partly by potentiating GABAergic responses, but they are not included here. (See all compounds classified as GABA Modulators.)

Hypnotics and Sedatives

Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. (See all compounds classified as Hypnotics and Sedatives.)

Adjuvants, Anesthesia

Agents that are administered in association with anesthetics to increase effectiveness, improve delivery, or decrease required dosage. (See all compounds classified as Adjuvants, Anesthesia.)

5.3 ATC Code

N - Nervous system

N05 - Psycholeptics

N05C - Hypnotics and sedatives

N05CA - Barbiturates, plain

N05CA01 - Pentobarbital

5.4 Absorption, Distribution and Excretion

Absorption

Barbiturates are absorbed in varying degrees following oral, rectal, or parenteral administration.

Route of Elimination

Barbiturates are metabolized primarily by the hepatic microsomal enzyme system, and the metabolic products are excreted in the urine, and less commonly, in the feces. Approximately 25 to 50 percent of a dose of aprobarbital or phenobarbital is eliminated unchanged in the urine, whereas the amount of other barbiturates excreted unchanged in the urine is negligible.

Nearly all of an oral or rectal dose of pentobarbital is absorbed from the GI tract. Following oral administration of pentobarbital, peak plasma concentrations are usually reached in 30-60 minutes.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

When pentobarbital is administered orally or rectally, the onset of action occurs within 15-60 minutes. The onset of action is within 1 minute following iv administration and within 10-25 minutes following im administration. Like secobarbital, pentobarbital probably has a duration of hypnotic effect of 1-4 hours following oral or rectal administration and about 15 minutes following iv administration.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

Plasma pentobarbital concentrations of 1-5 ug/mL generally produce sedation, and plasma concentrations of 5-15 ug/mL produce sleep in most patients; however, plasma concentrations of greater than 10 ug/mL may produce deep coma, and those in excess of 30 mcg/mL are potentially lethal.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

Approximately 35-45% of pentobarbital is bound to plasma proteins.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

For more Absorption, Distribution and Excretion (Complete) data for Pentobarbital (15 total), please visit the HSDB record page.

5.5 Metabolism/Metabolites

by hepatic microsomal enzyme system

Pentobarbital is metabolized by the liver chiefly by penultimate oxidation of the 1-methylbutyl substituent to a secondary alcohol, 5-ethyl-5-(3'-hydroxy-1'-methylbutyl) barbituric acid (hydroxypentobarbital) which is an inactive metabolite. Approximately 40-50% of an oral hypnotic dose of pentobarbital is excreted in urine as hydroxypentobarbital. The 1-methylbutyl substituent of pentobarbital can also be oxidized to form pentobarbital carboxylic acid, and small quantities of this metabolite have been found in urine.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

The liver biotransforms most ... short acting barbiturates (90%-99%). Short-acting compounds /eg, pentobarbital & secobarbital/ are oxidized to more polar & inactive compounds (alcohols, ketones, phenol, or carboxylic acid). /Barbiturates/

Ellenhorn, M.J. and D.G. Barceloux. Medical Toxicology - Diagnosis and Treatment of Human Poisoning. New York, NY: Elsevier Science Publishing Co., Inc. 1988., p. 575

Pentobarbital contains an asymmetric carbon atom in butyl side chain. Main route of metabolism is (omega-1)-oxidation to yield 5-ethyl-5-(3'-hydroxy-1'-methylbutyl)barbituric acid. This process creates a new center of asymmetry, thus giving rise to 4 possible diastereoisomeric metabolites.

Testa, B. and P. Jenner. Drug Metabolism: Chemical & Biochemical Aspects. New York: Marcel Dekker, Inc., 1976., p. 257

Metabolized by liver by ... oxidation of 1-methylbutyl substituent to ... 5-ethyl-5-(3-hydroxy-1-methylbutyl)barbituric acid (hydroxypentobarbital) /and/ pentobarbital carboxylic acid ... Glucuronide conjugates of alcohols /and further unidentified oxidation products also found in urine of /humans/.

American Society of Hospital Pharmacists. Data supplied on contract from American Hospital Formulary Service and other current ASHP sources., p. 1975

For more Metabolism/Metabolites (Complete) data for Pentobarbital (6 total), please visit the HSDB record page.

5.6 Biological Half-Life

5 to 50 hours (dose dependent)

Plasma concentrations of pentobarbital decline in a biphasic manner with a half-life of about 4 hours for the first phase and 35-50 hours for the second phase.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2583

The plasma half-life for pentobarbital in adults is 15 to 50 hours and appears to be dose dependent.

US Natl Inst Health; DailyMed. Current Medication Information for Nembutal sodium (pentobarbital sodium) injection (November 2006). Available from, as of March 19, 2010: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2563

Following iv admin of pentobarbitone sodium 50 mg to 5 healthy subjects pentobarbitone was noted to have a distribution phase (alpha-phase) of about 4 hr, & elimination occurred with a harmonic mean beta-phase half-life of about 50 hr. This suggested that for pentobarbitone the body has a central plasma compartment & one or more extravascular compartments. ... /In another study/ findings of 7 healthy subjects /revealed/ an average beta-phase half-life of only 22.3 hr following iv admin of 100 mg pentobarbitone sodium. After oral admin the half-life was about the same. A more detailed knowledge of pentobarbitone pharmacokinetics was needed to explain the deviation ... /between these 2 different studies/. /Pentobarbitone sodium/

Reynolds, J.E.F., Prasad, A.B. (eds.) Martindale-The Extra Pharmacopoeia. 28th ed. London: The Pharmaceutical Press, 1982., p. 810

5.7 Mechanism of Action

Pentobarbital binds at a distinct binding site associated with a Cl- ionopore at the GABAA receptor, increasing the duration of time for which the Cl- ionopore is open. The post-synaptic inhibitory effect of GABA in the thalamus is, therefore, prolonged. All of these effects are associated with marked decreases in GABA-sensitive neuronal calcium conductance (gCa). The net result of barbiturate action is acute potentiation of inhibitory GABAergic tone. Barbiturates also act through potent (if less well characterized) and direct inhibition of excitatory AMPA-type glutamate receptors, resulting in a profound suppression of glutamatergic neurotransmission.

The exact mechanism(s) by which barbiturates exert their effect on the CNS, has not been fully elucidated. However, it is believed that such effects are related, at least partially, to the drugs' ability to enhance the activity of gamma-aminobutyric acid (GABA), the principal inhibitory neurotransmitter in the CNS, by altering inhibitory synaptic transmissions that are mediated by GABAA receptors. /Barbiturates General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2579

Although the drugs act throughout the CNS, a site of particular sensitivity is the polysynaptic midbrain reticular formation which is concerned with the arousal mechanism. Barbiturates induce an imbalance in central inhibitory and facilitatory mechanisms influencing the cerebral cortex and the reticular formation. The significance of the effect of barbiturates on neurotransmitters is unclear. It appears that the drugs decrease the excitability of both presynaptic and postsynaptic membranes. It has not been determined which of the various actions of barbiturates at cellular and synaptic levels are responsible for their sedative and hypnotic effects. /Barbiturates General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2579

Relatively low doses of the barbiturates depress the sensory cortex, decrease motor activity, and produce sedation and drowsiness. In some patients, however, drowsiness may be preceded by a period of transient elation, confusion, euphoria, or excitement, especially after subhypnotic doses of aprobarbital, pentobarbital, or secobarbital. /Barbiturates General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2579

Larger doses distort judgment, cloud perception, suppress motor activity, and produce drowsiness and sleep. Still larger doses induce anesthesia. Barbiturate-induced sleep differs from physiologic sleep. Barbiturates reduce the rapid eye movement (REM) or dreaming stage of sleep. Stages III and IV sleep are also decreased. Although tolerance develops to the REM-suppressant effects during chronic administration, REM rebound occurs when the drugs are withdrawn, and the patient may experience markedly increased dreaming, nightmares, and/or insomnia. /Barbiturates General Statement/

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2579

For more Mechanism of Action (Complete) data for Pentobarbital (22 total), please visit the HSDB record page.

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Suanfarma, at the Core of a Better Life.

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Pentobarbital Sodium

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.

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Moehs Iberica

Spain

CPhI WW Frankfurt

Moehs Group, a reference company in the production of pharmaceutical active ingredients.

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Spain

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Pentobarbital Sodium

About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.

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Supriya Lifescience

India

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Not Confirmed

Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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India

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Pentobarbital Sodium

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.

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SCI Pharmtech

Taiwan

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Not Confirmed

SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.

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Taiwan

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Pentobarbital Sodium

About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...

SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and production facilities are fully equipped, and our experienced team ensures high-quality results. We work with pharmaceutical and specialty companies around the world to create important intermediates, APIs, and tailored products. Our facility meets FDA, EDQM, and Taiwan TFDA standards for versatile, large-scale manufacturing, ensuring reliable and compliant production processes.

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Henan Bon Chemical

China

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Not Confirmed

06

Ningbo Inno Pharmchem

China

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Not Confirmed

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ABOUT THIS PAGE

Pentobarbital Sodium Manufacturers

A Pentobarbital Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentobarbital Sodium, including repackagers and relabelers. The FDA regulates Pentobarbital Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentobarbital Sodium 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 Pentobarbital Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Pentobarbital Sodium Suppliers

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

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

Pentobarbital Sodium USDMF

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

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

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

Pentobarbital Sodium CEP

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

A Pentobarbital Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pentobarbital Sodium 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 Pentobarbital Sodium suppliers with CEP (COS) on PharmaCompass.

Pentobarbital Sodium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pentobarbital Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Pentobarbital Sodium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Pentobarbital Sodium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Pentobarbital Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentobarbital Sodium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Pentobarbital Sodium suppliers with NDC on PharmaCompass.

Pentobarbital Sodium GMP

Pentobarbital Sodium 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 Pentobarbital Sodium 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 Pentobarbital Sodium GMP manufacturer or Pentobarbital Sodium GMP API supplier for your needs.

Pentobarbital Sodium CoA

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

Pentobarbital Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Pentobarbital Sodium 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.

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