乳酸钠基本信息

Sodium Lactate
1Nonproprietary Names
BP:Sodium Lactate Solution
PhEur:Sodium Lactate Solution
USP:Sodium Lactate Solution
2Synonyms
E325;2-hydroxypropanoic acid monosodium salt;Lacolin;lactic acid monosodium salt;lactic acid sodium salt;natrii lactatis solutio; Patlac;Purasal;Ritalac NAL;sodium a-hydroxypropionate.
3Chemical Name and CAS Registry Number
Sodium lactate[72-17-3]
4Empirical Formula and Molecular Weight
C3H5NaO3112.06
5Structural Formula
The PhEur6.0and USP32describe sodium lactate solution as a mixture of the enantiomers of sodium2-hydroxypropanoate in approximately equal proportions.
6Functional Category
Antimicrobial preservative;buffering agent;emulsifying agent; flavoring agent;humectant.
7Applications in Pharmaceutical Formulation or Technology
Sodium lactate is widely used in cosmetics,(1,2)food products and pharmaceutical applications including parenteral and topical formulations.
Therapeutically,sodium lactate is used in infusions as a component of Ringer-lactate solution;as an alternative for sodium hydrogencarbonate in light acidosis;as a rehydrating agent;and as a carrier for electrolyte concentrates or medicines in perfusion/ infusion solutions.
8Description
Sodium lactate occurs as a clear,colorless,slightly syrupy liquid.It is odorless,or has a slight odor with a characteristic saline taste.It is hygroscopic.
9Pharmacopeial Specifications
See Table I.
Table I:Pharmacopeial specifications for sodium lactate.
Test PhEur6.0USP32 Charactersþ—IdentificationþþAppearance of solutionþ—
pH 6.5–9.0 5.0–9.0 Reducing sugars and sucroseþþMethanol450ppm(a)þ
Chlorides450ppm40.05% Oxalates and phosphatesþþ
Sulfates4100ppmþ
Aluminum40.1ppm(a)—
Bariumþ—
Iron410ppm—
Heavy metals410ppm40.001% Bacterial endotoxinsþ(b)—
Assay96.0–104.0%98.0–102.0%
(a)If intended for use in the manufacture of parenteral dosage forms,hemodialysis,or hemofiltration solutions.
(b)If intended for use in the manufacture of parenteral dosage forms without a further appropriate procedure for the removal of bacterial endotoxins.
10Typical Properties
Acidity/alkalinity pH=7for an aqueous solution.
Boiling point1128C
Hygroscopicity Very hygroscopic.
Melting point178C with decomposition at1408C.
Solubility Miscible with ethanol(95%),and with water. Specific gravity 1.31À1.34
11Stability and Storage Conditions
Sodium lactate should be stored in a well-closed container in a cool, dry,place.Sodium lactate is combustible and decomposes upon heating.
12Incompatibilities
See Lactic Acid.
13Method of Manufacture
See Lactic Acid.
14Safety
Sodium lactate occurs naturally in the body and is involved in physiological processes.It is generally regarded as a relatively nontoxic and nonirritant material when used as an excipient.Low concentrations are well tolerated by skin and eye mucosa,although higher concentrations should be avoided.
LD50(rat,IP):2g/kg(3)
15Handling Precautions
Observe normal precautions appropriate to the circumstances and quantity of material handled.Sodium lactate may cause eye irritation.When heated to decomposition,sodium lactate emits toxic fumes of Na2O.(3)
16Regulatory Status
GRAS listed(not for infant formulas).Included in the FDA Inactive Ingredient Database(epidural,IM,IV,and SC injections;oral suspensions;topical gels and solutions).Included in nonparenteral
650
medicines licensed in the UK.Included in the Canadian List of Acceptable Non-medicinal Ingredients.
17Related Substances
Lactic Acid.
18Comments
Generally,the commercially available product is a mixture with water containing70–80%sodium lactate.
The EINECS number for sodium lactate is200-772-0.The PubChem Compound ID(CID)for sodium lactate is23666456.
19Specific References
1Suomela A,Kristoffersson E.Dry skin and moisturizing agents.Acta Pharm Fenn1983;92(2):67–76.
2Middleton JD.Sodium lactate as a moisturizer.Cosmet Toiletries1978;
93(3):85–86.
3Lewis RJ,ed.Sax’s Dangerous Properties of Industrial Materials,11th edn.New York:Wiley,2004;2197–2198.
20General References
—
21Author
HJ de Jong.
22Date of Revision
13January
2009.
Sodium Lauryl Sulfate
1Nonproprietary Names
BP:Sodium Lauryl Sulphate
JP:Sodium Lauryl Sulfate
PhEur:Sodium Laurilsulfate
USP-NF:Sodium Lauryl Sulfate
2Synonyms
Dodecyl alcohol hydrogen sulfate,sodium salt;dodecyl sodium
sulfate;dodecylsulfate sodium salt;Elfan240;lauryl sodium
sulfate;lauryl sulfate,sodium salt;monododecyl sodium sulfate;
natrii laurilsulfas;sodium dodecyl sulfate;sodium n-dodecyl
sulfate;sodium laurilsulfate;sodium monododecyl sulfate;sodium
monolauryl sulfate;SDS;SLS;sulfuric acid monododecyl ester,
sodium salt;Texapon K12P.
3Chemical Name and CAS Registry Number
Sulfuric acid monododecyl ester sodium salt(1:1)[151-21-3]
4Empirical Formula and Molecular Weight
C12H25NaO4S288.38
The USP32–NF27describes sodium lauryl sulfate as a mixture of
sodium alkyl sulfates consisting chiefly of sodium lauryl sulfate
[CH3(CH2)10CH2OSO3Na].The PhEur 6.0states that sodium
lauryl sulfate should contain not less than85%of sodium alkyl
sulfates calculated as C12H25NaO4S.
5Structural
Formula
6Functional Category
Anionic surfactant;detergent;emulsifying agent;skin penetrant;
tablet and capsule lubricant;wetting agent.
7Applications in Pharmaceutical Formulation or
Technology
Sodium lauryl sulfate is an anionic surfactant employed in a wide
range of nonparenteral pharmaceutical formulations and cosmetics;
see Table I.
It is a detergent and wetting agent effective in both alkaline and
acidic conditions.In recent years it has found application in
analytical electrophoretic techniques:SDS(sodium dodecyl sulfate)
polyacrylamide gel electrophoresis is one of the more widely used
techniques for the analysis of proteins;(1)and sodium lauryl sulfate
has been used to enhance the selectivity of micellar electrokinetic
chromatography(MEKC).(2)
Table I:Uses of sodium lauryl sulfate.
Use Concentration(%)
Anionic emulsifier,forms self-emulsifying bases with
fatty alcohols
0.5–2.5
Detergent in medicated shampoos%10
Skin cleanser in topical applications1
Solubilizer in concentrations greater than critical
micelle concentration
>0.0025
Tablet lubricant 1.0–2.0
Wetting agent in dentrifices 1.0–2.0
8Description
Sodium lauryl sulfate consists of white or cream to pale yellow-
colored crystals,flakes,or powder having a smooth feel,a soapy,
bitter taste,and a faint odor of fatty substances.
9Pharmacopeial Specifications
See Table II.See also Section18.
Sodium Lauryl Sulfate651。