Methyl Paraben, Methylparaben, Abiol, Septos, Moldex, Metaben, Paridol, Solbrol, Nipagin, Metoxyde, Maseptol, Methaben, 99-76-3

Methyl Paraben, Methylparaben, Abiol, Septos, Moldex, Metaben, Paridol, Solbrol, Nipagin, Metoxyde, Maseptol, Methaben, 99-76-3

Methyl 4-hydroxybenzoate

CAS: 99-76-3

Molecular Formula: C8H8O3

Names and Identifiers

Physico-chemical Properties

Risk and Safety

Standard

This product is methyl 4-hydroxybenzoate, from methyl alcohol and parabens. Calculated as dry, containing C8H80 3 should be 98.0% ~ 102.0%.

Trait

• This product is white or off-white crystalline or crystalline powder.
• This product is soluble in methanol, ethanol or ether, soluble in hot water, slightly soluble in water.

melting point

The melting point of this product (General 0612) is 125~128°C.

Differential diagnosis

1. in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
2. take this product, dissolve and dilute with ethanol to make about 5 ml solution per lm l, and determine by UV-Vis spectrophotometry (General 0401), there is an absorption maximum at a wavelength of 258Nm.
3. The infrared absorption spectrum of this product should be consistent with the control spectrum (Spectrum set 853).

Exam

acidity

take 2ml of the solution under the items of clarity and color, add 2m l of ethanol and 5 m l of water, shake well, add 2 drops of bromocresol green indicator solution, with sodium hydroxide titration solution (O .lm o l/L) titration to blue, consumption of sodium hydroxide titration solution (0. lm o l/L) should not pass 0. lml.

clarity and color of solution

take this product l .O g, after dissolving with 0901 of ethanol, check according to law (General rule 0902 and general rule), the solution should be clear and colorless, it shall not be deeper than the yellow or yellow-green standard colorimetric solution No. 1 (General rule 0901 method 1).

chloride

take 2.0g of this product, add 50ml of water, 80X: water bath heating for 5 minutes, let cool, filter; Take the filtrate 5.0, check according to law (General rule 0801), with standard sodium chloride solution 7. Compared with the control solution made of 0M l, it should not be more concentrated (0. 035%).

sulfate

take 25ml of filtrate under chloride item and check according to law (pass 0802). Compared with the control solution made of 2. 4ml of standard potassium sulfate solution, it should not be more concentrated (0. 024%).

Related substances

take this product, add the mobile phase to dissolve and dilute the solution containing lm g per lm l as the test solution; Take lm l with precision and put it in a 100ml measuring flask, the mobile phase was diluted to the scale, and the solution was used as a control solution. According to the chromatographic conditions under the content determination item, 20 ml of the control solution is taken and injected into the human liquid chromatograph to adjust the detection sensitivity so that the peak height of the main component peak is about 25% of the full scale; then 20 ^ 1 of the test solution and the control solution were accurately measured, and the human liquid chromatograph was injected respectively, and the chromatogram was recorded to 4 times of the retention time of the main peak. If the impurity peak is shown in the chromatogram of the test solution, the area of the single impurity peak shall not be greater than 0 of the area of the main peak of the control solution. 4 times (0 .4% ), the sum of each impurity peak area shall not be greater than 0. 8 times (0. 8%).

fermentation broth

take an appropriate amount of this product, precision weighing, add an appropriate amount of N ,N-dimethylformamide, immediately shake to dissolve and dilute to make about O per lm l. lg of the solution, as the test solution; Another precision weighing the appropriate amount of methanol, plus JV ,N-dimethylformamide dissolved and diluted to make each lm l containing methanol 0 .3M g of solution, as a control solution. 0861 dimethylpolysiloxane was used as stationary liquid as determined by residual solvent determination method (General 100% third method); The starting temperature was 40°C, and the temperature was raised to 80°C at a rate of 15°C per minute for 5 minutes, then the temperature was raised to 130°C at a rate of every minute for 1 minute, and then raised to 220°C at a rate of 40°C per minute for 3 minutes; The temperature of the injection port was 200°C; the detector temperature was 250°C. 1ul of the reference solution is injected into the gas chromatograph, and the separation degree between peaks of each component shall meet the requirements. Take 1ul of each sample solution and reference solution respectively, inject human gas chromatograph, record chromatogram, calculate by peak area according to external standard method, and should not exceed 0.3%.

loss on drying

take this product, put it in a silica gel dryer, and dry it under reduced pressure to constant weight. The weight loss shall not exceed 0831 (general rule).

ignition residue

The l .O g of this product shall be taken for inspection according to law (General rule 0841), and the remaining residue shall not exceed.

Heavy metals

The residue left under the ignition residue item shall not contain more than 20 parts per million of heavy metals as determined by law (general chapter 0821 second method).

arsenic salt

take this product l.O g, add calcium hydroxide l.O g, mix, add a small amount of water, stir evenly, after drying, first burn with small fire to charring, then burn at 500~600°C to completely Ash and cool, add hydrochloric acid 5M l and water 23ML, according to the law inspection (General Principles 0822 The first law), should comply with the provisions (0.0002%).

Content determination

measured by high performance liquid chromatography (General 0512).

• chromatographic conditions and system applicability test using eighteen alkyl silane bonded silica gel as filler; Methanol -1% glacial acetic acid (60 : 40) as mobile phase, the detection wavelength was 254mn. Weigh the appropriate amount of the reference substance of methyl hydroxybenzoate and ethyl hydroxybenzoate, add the mobile phase to dissolve and dilute to make a solution containing 10 gm/l, inject 20ul into human liquid chromatograph, record the chromatogram, the degree of separation between the methyl paraben peak and the ethyl paraben peak should meet the requirements.
• determination method: take an appropriate amount of this product, precisely weigh it, add mobile phase to dissolve and quantitatively dilute it to make methyl oxybenzoate O in each lm l. lm g solution, the precise amount of 20ul injected into the liquid chromatograph, record the chromatogram; Another appropriate amount of methyl hydroxybenzoate reference substance, the same method for determination. According to the external standard method to calculate the peak area, that is.

Category

pharmaceutical excipients, bacteriostatic agents.

Storage

sealed storage.

Reference Information