Anhydrous Lactose is a white, crystalline powder derived from milk. It is used extensively in the pharmaceutical industry as an excipient due to its excellent binding properties and stability. It is also used in food products as a sweetener and filler.
Sinezimboni eziningi zekhwalithi ephezulu ngokubambisana okujulile, ezingakunikeza ngemikhiqizo yekhwalithi ephezulu namanani ancintisanayo. Futhi singanikeza izaphulelo zokuthenga ngobuningi.Futhi sibambisana nezinkampani eziningi ezichwepheshile zokudlulisa impahla, zingaletha imikhiqizo ngokuphepha nangokushelela ezandleni zakho. Isikhathi sokulethwa cishe yizinsuku ezi-3-20 ngemuva kokuqinisekiswa kwenkokhelo.
Test items | Criterion | Imiphumela | |||
Identification A | The infrared absorption spectrum of the sample is concordant with that of the standard. | Iyahambisana | |||
Identification B | The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. | Iyahambisana | |||
The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots, disregarding any spots at the origin. | |||||
Residue on ignition | Not more than 0.1% | 0.03% | |||
Heavy metals | Not more than 5µg per g. | Iyahambisana | |||
Clarity and color of solution | The solution (1g in 10ml of boiling water) is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length, in cm, is not more than 0.04. | Complies 0.01 | |||
Optical rotation | +54.4°~+55.9°, calculate on the anhydrous basis, determined at 20° | +55.2° | |||
Acidity or alkalinity | Add 0.3ml of phenolphthalein TS: the solution is colorless, and not more than 0.4 ml of 0.1 N sodium hydroxide is required to produce a pink to red color. | Iyahambisana | |||
Loss on drying | Dry a sample at 80° for 2 h. not more than 0.5% | 0.08% | |||
Water | 4.5%~5.5% | 5.2% | |||
Protein and light-absorbing impurities | 210-220 nm: Not more than 0.25 270-300 nm: Not more than 0.07 | 0.03 0.01 | |||
TAMC (cfu/g) | <100 | <10 | |||
Molds and Yeasts (cfu/g) | <50 | <10 | |||
Escherichia coli (/10g) | absence | Not detected | |||
Assaying | This product is 4-O-β-D- pyran galactosyl -D-glucose monohydrate. The content of C12H22O11 should be 98.0%~102.0%. | 99.6% | |||
Acidity | Take 1.0g of this product, and the pH value should be 4.0~7.0. | 4.7 | |||
Conclusion : | The Quality of lactose product has the achieved standard of USP30 after examination standard examination, and consequently meet the provision. |
1. Ingabe uyimboni noma inkampani yokuhweba?
Siyimboni ehlanganisa i-comnay kanye nezohwebo, sinikeza isevisi eyodwa-stop.OEM ingamukelwa.
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Isitifiketi se-ISO 9001:2008 sokuqinisekisa ikhwalithi.
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