Aloe vera juice, gel, extract and powder

Aloe vera is a succulent plant species an evergreen perennial that grows wild in tropical, semi-tropical, and arid climates around the world. It is cultivated for agricultural and medicinal uses. It is found in many consumer products including beverages, skin lotion, cosmetics, or ointments for minor burns and sunburns. Aloe vera juice, paste and powder are used to manufacture commercial products. Aloe vera may be prepared as a lotion, gel, soap, or cosmetics product for use on skin as a topical medication.

General Specifications of Aloe vera juice:
Appearance: Almost colorless liquid
pH 3.5~5
Soluble solid: 0.5% minimum.
Total bacterial count (cfu/ml): 100 maximum.
Coliform(MPN/100ml): 3 maximum.
Mildew(cfu/ml): 10 maximum.
Pathogenic bacterium: Negative.

General Specifications of Aloe vera gel:
Color: Pale translucent.
Odor: Mild characteristic odor.
Pesticide residues: Negative
pH: 3.5 to 5
Aerobic Plate Count - <10 CFU/G
Mold: <10 cfu/g.
Yeast Mold: <10 cfu/g.
Pathogens: Absent
Preservative: Sodium Benzoate - 0.10%, Potassium Sorbate - 0.10%, Citric Acid - 0.12%

General Specifications of Aloe vera powder:
Appearance: Clear to off-white powder.
Taste: Sour, characteristic Aloe.
Arsenic(As2O3): 1 ppm maximum.
Lead: 2 ppm maximum.
Copper (Cu): 10 ppm maximum.
Mercury (Hg): 0.01 ppm maximum.
pH (0.5% w/w water solution): 3.5 to 5
Total Aerobic Plate Count: < 3,000 CFU / g
Yeast: <= 100 cfu/g.
Mold: <= 100 cfu/g.
Coliform: < 100 mpn/g
E. Coli: Negative
Salmonella: Negative
Staphylococcus aureus: Negative.

Specifications of Aloe USP Grade:
Aloe vera

DEFINITION
Aloe is the dried latex of the leaves of Aloe vera (L.) Burm. f. (syn. Aloe barbadensis Mill.), known in commerce as aloe vera, Curaçao aloe, or Barbados aloe; or of Aloe ferox Mill; or of hybrids of Aloe ferox Mill. with Aloe africana Mill, and Aloe spicata L.f., known in commerce as cape aloe (Fam. Liliaceae). Aloe vera contains NLT 16.0% of aloin and cape aloe and its hybrids contain NLT 6.0% of aloin, both calculated on the dried basis.

IDENTIFICATION
A.
Sample: 1 g finely powdered
Analysis: Mix the Sample with 25 mL of cold water. Shake the mixture occasionally during 2 h, filter, and wash the filter and residue with sufficient cold water to make the filtrate measure 100 mL.
Acceptance criteria: The color of the filtrate, viewed in the bulb of a 100-mL volumetric flask, is dark orange with curaçao aloe and greenish yellow with cape aloe. The filtrate darkens on standing. [Note— Reserve the filtrate for Identification test B.]
B.
Sample: 5 mL of the filtrate obtained in Identification test A
Analysis: Add 2 mL of nitric acid to the Sample, and mix.
Acceptance criteria: The mixture exhibits a reddish-orange color with aloe vera and a reddish-brown color that changes rapidly to green with cape aloe.
C. Thin-Layer Chromatography
To pass the test.
Acceptance criteria: Under visible light, the Sample solution chromatogram exhibits a brown band due to aloin at about the middle of the chromatogram, corresponding in color and R F to the band exhibited by the Standard solution. Sample solution containing aloe vera exhibits an additional violet band due to 7-hydroxyaloin right below the aloin band. Sample solution containing cape aloe lacks the violet band due to 7-hydroxyaloin. Under UV light at 365 nm, the Sample solution chromatogram exhibits a yellow fluorescence band due to aloin, corresponding in color and R F to the band exhibited by the Standard solution, and a light blue fluorescence band due to aloesine at about one third of the chromatogram.

ASSAY
Content of Aloin:
To pass the test.
Acceptance criteria: Aloe vera contains NLT 16.0% of aloin, and cape aloe and its hybrids contain NLT 6.0% of aloin, both calculated on the dried basis.

Water-Soluble Extractive:
Sample: 2 g of powdered Aloe
Analysis: Macerate the Sample in 70 mL of water in a suitable flask. Shake the mixture during 8 h at 30-min intervals and allow it to stand for 16 h without shaking. Filter, and wash the flask and residue with small portions of water, passing the washings through the filter until the filtrate measures 100.0 mL. Evaporate a 50-mL aliquot of the filtrate in a tared dish on a steam bath to dryness, and dry at 110C to constant weight.
Acceptance criteria: The weight of water-soluble extractive so obtained is NLT 50% of the weight of Aloe taken.
Loss on Drying:
Sample: Use a powdered sample. If the Aloe is not powdered, crush it in a mortar until it passes through a no. 40 sieve, and mix the ground material before weighing the sample.
Analysis: Dry at 105C for 5 h.
Acceptance criteria: NMT 12.0%
Articles of Botanical Origin, Total Ash:
Acceptance criteria: NMT 4.0%
Alcohol-Insoluble Substances:
Sample: 1 g of powdered Aloe
Analysis: Add the Sample to 50 mL of alcohol in a flask. Heat the mixture to boiling, and maintain at incipient boiling for 15 min, replacing any loss due to evaporation. Remove from the heat and shake the mixture at intervals during 1 h. Pass through a small dried and tared filter paper or a dried and tared filtering crucible and wash the residue on the filter with alcohol until the last washing is colorless. Dry the residue at 105C to constant weight.
Acceptance criteria: The weight of the residue is NMT 10.0% of the weight of Aloe taken.
Botanic Characteristics:
Curaçao aloe: Brownish black, opaque masses. Its fractured surface is uneven, waxy, and somewhat resinous.
Cape aloe: Dusky to dark brown irregular masses, the surfaces of which are often covered with a yellowish powder. Its fracture is smooth and glassy.
Powdered aloe: Yellow, yellowish brown to olive-brown in color. When mounted in olive oil, it appears as greenish-yellow to reddish-brown irregular fragments, the hues of which depend to some extent upon the thickness of the fragments.

Specifications of Barbados Aloes BP Ph Eur Grade:
Curaçao Aloes
Preparation: Standardised Aloes Dry Extract.

DEFINITION
Concentrated and dried juice of the leaves of Aloe barbadensis Miller.
Content: Minimum 28.0 per cent of hydroxyanthracene derivatives, expressed as barbaloin (C21H22O9; M r 418.4) (dried drug).

CHARACTERS
Appearance: Dark brown masses, slightly shiny or opaque with a conchoidal fracture, or brown powder.
Solubility: Partly soluble in boiling water, soluble in hot ethanol (96 per cent).

IDENTIFICATION
A. Thin-layer chromatography: To pass the test.
B. Shake 1 g of the powdered drug with 100 ml of boiling water. Cool, add 1 g of talc and filter. To 10 ml of the filtrate add 0.25 g of disodium tetraborate and heat to dissolve.
Pour 2 ml of this solution into 20 ml of water. Yellowish-green fluorescence appears which is particularly marked in ultraviolet light at 365 nm.
C. To 5 ml of the filtrate obtained in identification test B add 1 ml of freshly prepared bromine water. A brownish-yellow precipitate is formed, and the supernatant liquid is violet.

TESTS
Loss on drying: Maximum 12.0 per cent, determined on 1.000 g of the powdered drug by drying in an oven at 105C.
Total ash: Maximum 2.0 per cent.

ASSAY
Carry out the assay protected from bright light.
Introduce 0.300 g of powdered drug (180) (2.9.12) into a 250 ml conical flask. Moisten with 2 ml of methanol, add 5 ml of water warmed to about 60C, mix, then add a further 75 ml of water at about 60C and shake for 30 min. Cool, filter into a volumetric flask, rinse the conical flask and filter with 20 ml of water, add the rinsing to the volumetric flask and dilute to 1000.0 ml with water. Transfer 10.0 ml of this solution to a 100 ml round bottomed flask containing 1 ml of a 600 g/l solution of ferric chloride and 6 ml of hydrochloric acid. Heat in a water-bath under a reflux condenser for 4 h, with the water level above that of the liquid in the flask. Allow to cool, transfer the solution to a separating funnel, rinse the flask successively with 4 ml of water, 4 ml of 1 M sodium hydroxide and 4 ml of water and add the rinsing to the separating funnel. Shake the contents of the separating funnel with 3 quantities, each of 20 ml, of ether. Wash the combined ether layers with 2 quantities, each of 10 ml, of water. Discard the washings and dilute the organic phase to 100.0 ml with ether. Evaporate 20.0 ml of the solution carefully to dryness on a water-bath and dissolve the residue in 10.0 ml of a 5 g/l solution of magnesium acetate in methanol. Measure the absorbance at 512 nm using methanol as the compensation liquid.
Calculate the percentage content of hydroxyanthracene derivatives, as barbaloin, from the following expression:

A*19.6/m
i.e. taking the specific absorbance of barbaloin to be 255.

A = absorbance at 512 nm,
M = mass of the substance to be examined, in grams.

STORAGE
In an airtight container.