Stability studies / Shelf life:
Stability studies / Shelf life: Shelf-life refers to the period from initial preparation to packaging during which the drug dosage form continues to remain within its physical, chemical, therapeutic and toxicological specifications at specified storage conditions.The stability of the product is its ability to resist deterioration. It is always expressed in terms of shelf life. Natural Remedies offers stability management services for Active Neutraceutical Ingredients (APIs) and finished products. The facilities are equipped with temperature and humidity-controlled chambers that are continuously monitored and alarmed for any environmental changes. All the chambers undergo stringent IQ, OQ, PQ and calibration processes on a yearly basis and are fully mapped (empty and full) for both temperature and humidity to ensure temperature/humidity uniformity. The chambers meet complete ICH conditions, including 25°C/60% RH, 30°C/65% RH, 40°C/75%RH, 5°C.
# | Botanical Name | Marker(s) / active compounds |
---|---|---|
1 | Acorus calamus | a-asarone |
2 | Adhatoda vasica | Vasicine |
3 | Aegle marmelos | Marmelosin |
4 | Albizia lebbeck | (+)-Catechin |
5 | Aloe vera | Aloin |
6 | Andrographis paniculata | Andrographolide |
7 | Anethum sowa | Anethol |
8 | Asparagus racemosus | Shatavarin-I and Shatavarin-IV |
9 | Bacopa monnieri | Bacoside-A |
10 | Berberis aristata | Berberine |
11 | Boerhaavia diffusa | Eupalitin& Eupalitin-3-O-galactoside |
12 | Boswellia serrata | Acetyl keto boswellic acid, Keto Boswellic acid |
13 | Capsicum annum | Capsaicin |
14 | Cassia angustifolia | Sennosides |
15 | Cassia tora | Chrysophanol |
16 | Coleus forskohlii | Forskolin |
17 | Commiphora mukul | Guggulsterone-E & Z |
18 | Curcuma longa | Curcumin |
19 | Eclipta alba | Wedelolactone |
20 | Gardenia gummifera | Gardenin |
21 | Gloriosa superba | Colchicine |
22 | Glycyrrhiza glabra | Glycyrrhizin |
23 | Gymnema sylvestre | Gymnemagenin |
24 | Largerstroemia speciosa | Corosolic acid |
25 | Mallotus philippensis | Rottlerin |
26 | Mangifera indica | Mangiferin |
27 | Mangifera indica | Mangiferin |
28 | Mucuna pruriens | L-Dopa |
29 | Ocimum tenuiflorum | Rosemarinic acid, Ursolic acid |
30 | Peganum harmala | Harmaline, Harmine |
31 | Phyllanthus amarus | Phyllanthin, Hypophyllanthin |
32 | Piper longum / Piper nigrum | Piperine |
33 | Plumbago zeylanica | Plumbagin |
34 | Psoralea corylifolia | Psoralen |
35 | Terminalia arjuna | Arjungenin, Arjunic acid |
36 | Tribulus terrestris | Tribulosin |
37 | Trigonella-foenum-graecum | Trigonelline |
38 | Valeriania officinalis | Valerenic acid |
39 | Vitex negundo | Agnuside |
40 | Withania somnifera | Withanolide-A & B, Withastramonolide, Withanoside- IV & V, Withaferin-A |
41 | Zingiber officinale | 6-gingerol, 6-Shogaol, 8-gingerol |
# | Botanical Name | Marker(s) / active compounds |
---|---|---|
1 | Acacia catechu | Catechins |
2 | Adhatoda vasica | Vasicine |
3 | Aegle marmelos | Marmelosin |
4 | Aesculus indica | b-escin |
5 | Andrographis paniculata | Andrographolide |
6 | Aristolochia indica | Aristolochic acid |
7 | Bacopa monnieri | Bacoside A, Bacopaside I, Bacosine |
8 | Bacopa monnieri | Bacoside-A |
9 | Berberis aristata | Berberine |
10 | Boswellia serrata | Boswellic acids |
12 | Camellia sinensis | EGCG (Epigalocatechin gallate) and Total Catechins |
13 | Cassia angustifolia | Sennosides A & B |
14 | Cassia tora | Chrysophanol |
15 | Capsicum annum | Capsaicin |
16 | Centella asiatica | Asiaticoside and Madecassoside |
17 | Coleus forskohlii | Forskolin |
18 | Chrysanthemum parthenium | Parthenolide |
19 | Curcuma longa | Curcumin |
20 | Eclipta alba | Wedelolactone & demethylwedelolactone |
21 | Embelia ribes | Embelin |
22 | Ferula asafoetida | Ferulic acid |
23 | Garcinia cambogia | Hydroxy citric acid |
24 | Garcinia mangostana | Mangostin |
25 | Gardenia gummifera | Gardenin |
26 | Gloriosa superba | Colchicine |
27 | Glycyrrhiza glabra | Glabridin |
28 | Glycyrrhiza glabra | Glycyrrhizin |
29 | Gymnema sylvestre | Gymnemagenin |
30 | Hypericum perforatum | Hypericin |
31 | Lagerstroemia speciosa | Corosolic acid |
32 | Mallotus philippensis | Rottlerin |
33 | Mangifera indica | Mangiferin |
34 | Mucuna pruriens | L-Dopa |
35 | Ocimum tenuiflorum | Rosemarinic acid & Ursolic acid |
36 | Peganum harmala | Harmine & Harmaline |
37 | Phyllanthus amarus | Phyllanthin and Hypophyllanthin |
38 | Plumbago zeylanica | Plumbagin |
By GC | ||
39 | Crataeva nurvala | Lupeol |
40 | Hedychium spicatum | Para methoxy ethyl cinnamate |
41 | Ocimum Tenuiflorum | Ursolic and Oleanolic acid |
42 | Valeriania officinalis | Valerenic acid |
By HPTLC | ||
43 | Asparagus racemosus | Shatavarin-I and Shatavarin-IV |
44 | Trigonella graceum | 4-Hydroyisoleucine |
# | # | ||
---|---|---|---|
1 | Solubility | 27 | Acid Value |
2 | Ash | 28 | Saponification value |
3 | Acid Insoluble ash | 29 | Peroxide value |
4 | pH | 30 | Free fatty acids |
5 | Bulk Density | 31 | Hydroxyl value |
6 | Aristolochia indica | 32 | Ester value |
7 | Tapped Bulk Density | 33 | Acetyl value |
8 | Total Soluble Solids | 34 | Unsapamisiable value |
9 | Average Weight | 35 | Iodine Value |
10 | Uniformity of Weight | 36 | Friability test |
11 | Average Fill | 37 | Total Foreign matter |
12 | Variation from Average Fill | 38 | Total Dissolved Solids |
13 | Disintegration Test | 39 | Ether Soluble Extractive(Fixed Oil) |
14 | Hardness Test | 40 | Crude Fibre |
15 | Specific Gravity | 41 | Protein / Nitrogen Estimation |
16 | Weight / ml | 42 | Pressure Test in Aerosols |
17 | Acidity | 43 | Leakage Test in Aerosols |
18 | Loss on Drying at 105°C | 44 | Peroxide value |
19 | Spreadability | 45 | Sedimentation Test in Aerosols |
20 | Clarity of Solution | 46 | Optical Rotation |
21 | Consistency | 47 | Specific Optical Rotation |
22 | Melting Range | 48 | Determination of Cineole |
23 | Boiling Range | 49 | Loss on ignition |
24 | Congealing Temperature | 50 | Sulphated ash |
25 | Refractive index | 51 | Particle Size |
26 | Viscosity By Brookfield |
# | Solvent Analysis by GC Head Space |
---|---|
1 | Methanol |
2 | Ethanol |
3 | Acetone |
4 | Hexane |
5 | Ethylacetate |
6 | EDC |
7 | n-butanol |
8 | Toluene |
9 | Tetrahydrofuran |
10 | Dichloromethane |
# | Polycyclic Aromatic Hydrocarbons (PAHs) |
---|---|
1 | benz[a]anthracene |
2 | benzo[a]pyrene |
# | Heavy metal analysis |
---|---|
1 | Lead |
2 | Mercury |
3 | Arsenic |
4 | Cadmium |
# | Mycotoxins |
---|---|
1 | Aflatoxins (B1 + B2 + G1 + G2) |
2 | Ochrotoxins (A & B) |
# | Naturally Occuring Toxins Test |
---|---|
1 | Aristolocholic acid |
2 | Hypericin |
3 | Harmal alkaloids |
4 | Coumarin |
5 | Methyl eugenol |
# | Other metals |
---|---|
1 | Zinc |
2 | Copper |
3 | Aluminium |
4 | Chromium |
5 | Cobalt |
6 | Copper |
7 | Iron |
8 | Manganese |
9 | Barium |
10 | Tin |
11 | Nickle |
12 | Beryllium |
13 | Vanadium |
14 | Molybdenum |
Minimum Inhibitory Concentration (MIC):
The MIC test determines antimicrobial activity of a material against a specific bacteria. The lowest concentration of the test agent that allows no growth/ no more than one or two CFU/ only a slight haze to grow is the MIC. The minimal bactericidal concentration (MBC) or the minimum lethal concentration (MLC) is defined as the lowest concentration of the test agent that will kill a test organism, MLC cannot be done without testing for MIC.
Zone of Inhibition:
This method is used to demonstrate activity / potency of antimicrobials or antibiotics /plant materials by measuring the zone of inhibition against specified microorganisms. This method is very useful for screening of large number of test agents for their antimicrobial activities. The test agents showing good antimicrobial activity can then be taken for MIC studies.
Bioburden Testing:
Bioburden testing will provide an estimate of the total number of bacteria, fungus, etc. present in your sample. Bioburden testing on the products and other ingredients used in the pharmaceutical /food/nutraceutical industry provide control of microbial levels. Bioburden testing determines the number of viable microorganisms on a product.
Environmental Monitoring (Surface testing, equipment testing, air monitoring, glove print)*
The Environmental (Microbial) monitoring programs for controlled environments should assess the effectiveness of the cleaning and sanitation practices by and of the personnel that could have an impact on the bioburden of the controlled environment. Microbial monitoring, regardless of how sophisticated the system may be, will not and need not identify and quantitative all microbial contaminants present in controlled environments. Routine microbiological monitoring should provide sufficient information to ascertain that the controlled environment is operating within an adequate state of control.
The Environmental monitoring program includes an appropriate level of identification of the flora obtained from sampling. A knowledge of the normal flora in controlled environments aids in determining the usual microbial flora anticipated for the facility being monitored, evaluating the effectiveness of the cleaning and sanitation procedures, methods and agents and recovery methods.
Water analysis*
Bacteriological water analysis is a method of analyzing water to estimate the numbers of bacteria present and, if needed, to find out what sort of bacteria they are. It is a microbiological analytical procedure which uses samples of water and from these samples determines the concentration of bacteria. It is then possible to draw inferences about the suitability of the water for use from these concentrations. This process is used, for example, to routinely confirm that water is safe for human consumption or that bathing and recreational waters are safe to use.
The interpretation and the action trigger levels for different waters vary depending on the use made of the water. Very stringent levels applying to drinking water whilst more relaxed levels apply to marine bathing waters where much lower volumes of water are expected to be ingested by users.
Note: *Services available within Bangalore