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Magnesium stearate (Stearic Acid Magnesium(II) Salt)

Cat No.:V66032 Purity: ≥98%
Magnesium stearate is a extensively usedmedicinal lubricant.
Magnesium stearate (Stearic Acid Magnesium(II) Salt)
Magnesium stearate (Stearic Acid Magnesium(II) Salt) Chemical Structure CAS No.: 557-04-0
Product category: Biochemical Assay Reagents
This product is for research use only, not for human use. We do not sell to patients.
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Product Description
Magnesium stearate is a extensively usedmedicinal lubricant. But Magnesium stearate can adversely affect the bonding between particles. Magnesium stearate could be utilized as pharmaceutical excipients such as lubricants. Pharmaceutical excipients or pharmaceutical auxiliaries refer to other chemical substances other than drug ingredients used in the pharmaceutical process. Pharmaceutical excipients generally refer to inactive ingredients in pharmaceutical preparations, which can improve the stability, solubility and processability of pharmaceutical preparations. Pharmaceutical excipients can also affect the absorption, distribution, metabolism, and elimination (ADME) processes of co-administered drugs.
Magnesium stearate (CAS 557-04-0) is the magnesium salt of stearic acid with molecular formula C36H70MgO4 and molecular weight 591.24. It appears as a fine, light white powder with a slippery feel, insoluble in water, ethanol, and ether, but soluble in hot water and hot ethanol. This compound is primarily used as a lubricant in capsule and tablet manufacture. It is a widely used pharmaceutical excipient in the production of medical tablets, capsules, powders, and polymer formulations.
Biological Activity I Assay Protocols (From Reference)
Targets
Magnesium stearate does not have a defined pharmacological target as it is a pharmaceutical excipient rather than a therapeutic agent. The compound is used as a lubricant, anti-adherent, and glidant in tablet and capsule formulations. It reduces friction between particles and between the tablet formulation and the compression equipment during manufacturing. Its function is to improve the manufacturing process rather than to interact with biological targets.
ln Vitro
No specific in vitro pharmacological activity data are available for magnesium stearate as it is a pharmaceutical excipient. In research settings, the compound is evaluated for its lubricating properties, flow characteristics, and compatibility with active pharmaceutical ingredients. Its activity is assessed in terms of formulation performance, tablet hardness, and disintegration time rather than direct biological activity.
ln Vivo
No specific in vivo pharmacological activity data have been documented for magnesium stearate as it is a pharmaceutical excipient. The compound is used in drug formulations to improve manufacturability and is not administered for therapeutic purposes. It is generally considered pharmacologically inert and is not absorbed to a significant extent after oral administration.
Enzyme Assay
For non-cellular assays, magnesium stearate is characterized by standard analytical techniques including FTIR, X-ray diffraction, and elemental analysis to confirm identity and purity. The compound can be evaluated for its lubricating properties using tablet compression studies. Typical protocols involve mixing the compound with formulation components and measuring tablet hardness, ejection force, and disintegration time. Content of magnesium: 4.00 to 5.00%. Stearic acid composition: min. 60.0%.
Cell Assay
For in vitro cell-based studies, magnesium stearate is not typically used as a direct test compound. The compound is used as an excipient in pharmaceutical formulations that are subsequently tested in cell-based assays. If handled in a biological laboratory context, standard safety precautions should be taken. The compound should be stored in a cool, dry place.
Animal Protocol
For in vivo animal studies, magnesium stearate is used as an excipient in pharmaceutical formulations administered to animals. The compound is generally considered safe for use in oral formulations. Dosing and administration follow the specific formulation protocol. Standard animal welfare guidelines should be followed for all in vivo studies.
ADME/Pharmacokinetics
Magnesium stearate has a molecular weight of 591.24 and molecular formula C36H70MgO4. It appears as a fine, light white powder with a slippery feel. Content of magnesium: 4.00 to 5.00%. Stearic acid composition: min. 60.0%. Storage: keep in a cool, dry place. The compound is insoluble in water, ethanol, and ether, but soluble in hot water and hot ethanol.
Toxicity/Toxicokinetics
Toxicity Summary
The CIR expert panel concluded that, at the current methods of use and concentrations described in the safety assessment, the following ingredient is safe when formulated as non-irritating and non-allergenic, possibly based on a quantitative risk assessment (QRA)... Magnesium stearate is safe for use in cosmetics, but subject to specific conditions.
Magnesium stearate is generally regarded as safe for use as a pharmaceutical excipient at appropriate concentrations. The compound is orally non-toxic, but large doses may cause diarrhea or mucosal irritation. Standard laboratory safety practices should be followed when handling this compound. Appropriate personal protective equipment including gloves and safety glasses should be worn.
References

[1]. Effect of magnesium stearate on bonding and porosity expansion of tablets produced from materials with different consolidation properties. International journal of pharmaceutics, 1999, 179(1): 107-115.

[2]. Pharmaceutical excipients - quality, regulatory and biopharmaceutical considerations. Eur J Pharm Sci. 2016 May 25;87:88-99.

Additional Infomation
Magnesium distearate is a magnesium salt, and also an organomagnesium salt. See also: stearic acid (containing the active portion).
Magnesium stearate (CAS 557-04-0) is also known as magnesium distearate and stearic acid magnesium(II) salt. It is a widely used pharmaceutical excipient, lubricant, and anti-adherent in capsule and tablet manufacture. The compound is used in the production of medical tablets, capsules, powders, and polymer formulations. No therapeutic claims exist for the compound itself.
These protocols are for reference only. InvivoChem does not independently validate these methods.
Physicochemical Properties
Molecular Formula
C36H70MGO4
Molecular Weight
591.24
Exact Mass
590.512
CAS #
557-04-0
PubChem CID
11177
Appearance
LUMPS
Fine, bulky, white powder
Soft, white, light powder
Density
1.028g/cm3
Boiling Point
359.4ºC at 760mmHg
Melting Point
88.5 °C (pure) ; MP: 132 °C /Technical/ ; 88 °C
Flash Point
162.4ºC
Index of Refraction
1.45 (25ºC)
LogP
12.508
Hydrogen Bond Donor Count
0
Hydrogen Bond Acceptor Count
4
Rotatable Bond Count
30
Heavy Atom Count
41
Complexity
196
Defined Atom Stereocenter Count
0
SMILES
[Mg+2].[O-]C(C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H])=O.[O-]C(C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H])=O
InChi Key
HQKMJHAJHXVSDF-UHFFFAOYSA-L
InChi Code
InChI=1S/2C18H36O2.Mg/c2*1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-18(19)20;/h2*2-17H2,1H3,(H,19,20);/q;;+2/p-2
Chemical Name
magnesium;octadecanoate
HS Tariff Code
2934.99.9001
Storage

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Note: Please store this product in a sealed and protected environment, avoid exposure to moisture.
Shipping Condition
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
Solubility Data
Solubility (In Vitro)
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
Solubility (In Vivo)
Note: Listed below are some common formulations that may be used to formulate products with low water solubility (e.g. < 1 mg/mL), you may test these formulations using a minute amount of products to avoid loss of samples.

Injection Formulations
(e.g. IP/IV/IM/SC)
Injection Formulation 1: DMSO : Tween 80: Saline = 10 : 5 : 85 (i.e. 100 μL DMSO stock solution 50 μL Tween 80 850 μL Saline)
*Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH ₂ O to obtain a clear solution.
Injection Formulation 2: DMSO : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL DMSO 400 μLPEG300 50 μL Tween 80 450 μL Saline)
Injection Formulation 3: DMSO : Corn oil = 10 : 90 (i.e. 100 μL DMSO 900 μL Corn oil)
Example: Take the Injection Formulation 3 (DMSO : Corn oil = 10 : 90) as an example, if 1 mL of 2.5 mg/mL working solution is to be prepared, you can take 100 μL 25 mg/mL DMSO stock solution and add to 900 μL corn oil, mix well to obtain a clear or suspension solution (2.5 mg/mL, ready for use in animals).
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Injection Formulation 4: DMSO : 20% SBE-β-CD in saline = 10 : 90 [i.e. 100 μL DMSO 900 μL (20% SBE-β-CD in saline)]
*Preparation of 20% SBE-β-CD in Saline (4°C,1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.
Injection Formulation 5: 2-Hydroxypropyl-β-cyclodextrin : Saline = 50 : 50 (i.e. 500 μL 2-Hydroxypropyl-β-cyclodextrin 500 μL Saline)
Injection Formulation 6: DMSO : PEG300 : castor oil : Saline = 5 : 10 : 20 : 65 (i.e. 50 μL DMSO 100 μLPEG300 200 μL castor oil 650 μL Saline)
Injection Formulation 7: Ethanol : Cremophor : Saline = 10: 10 : 80 (i.e. 100 μL Ethanol 100 μL Cremophor 800 μL Saline)
Injection Formulation 8: Dissolve in Cremophor/Ethanol (50 : 50), then diluted by Saline
Injection Formulation 9: EtOH : Corn oil = 10 : 90 (i.e. 100 μL EtOH 900 μL Corn oil)
Injection Formulation 10: EtOH : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL EtOH 400 μLPEG300 50 μL Tween 80 450 μL Saline)


Oral Formulations
Oral Formulation 1: Suspend in 0.5% CMC Na (carboxymethylcellulose sodium)
Oral Formulation 2: Suspend in 0.5% Carboxymethyl cellulose
Example: Take the Oral Formulation 1 (Suspend in 0.5% CMC Na) as an example, if 100 mL of 2.5 mg/mL working solution is to be prepared, you can first prepare 0.5% CMC Na solution by measuring 0.5 g CMC Na and dissolve it in 100 mL ddH2O to obtain a clear solution; then add 250 mg of the product to 100 mL 0.5% CMC Na solution, to make the suspension solution (2.5 mg/mL, ready for use in animals).
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Oral Formulation 3: Dissolved in PEG400
Oral Formulation 4: Suspend in 0.2% Carboxymethyl cellulose
Oral Formulation 5: Dissolve in 0.25% Tween 80 and 0.5% Carboxymethyl cellulose
Oral Formulation 6: Mixing with food powders


Note: Please be aware that the above formulations are for reference only. InvivoChem strongly recommends customers to read literature methods/protocols carefully before determining which formulation you should use for in vivo studies, as different compounds have different solubility properties and have to be formulated differently.

 (Please use freshly prepared in vivo formulations for optimal results.)
Preparing Stock Solutions 1 mg 5 mg 10 mg
1 mM 1.6914 mL 8.4568 mL 16.9136 mL
5 mM 0.3383 mL 1.6914 mL 3.3827 mL
10 mM 0.1691 mL 0.8457 mL 1.6914 mL

*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.

Calculator

Molarity Calculator allows you to calculate the mass, volume, and/or concentration required for a solution, as detailed below:

  • Calculate the Mass of a compound required to prepare a solution of known volume and concentration
  • Calculate the Volume of solution required to dissolve a compound of known mass to a desired concentration
  • Calculate the Concentration of a solution resulting from a known mass of compound in a specific volume
An example of molarity calculation using the molarity calculator is shown below:
What is the mass of compound required to make a 10 mM stock solution in 5 ml of DMSO given that the molecular weight of the compound is 350.26 g/mol?
  • Enter 350.26 in the Molecular Weight (MW) box
  • Enter 10 in the Concentration box and choose the correct unit (mM)
  • Enter 5 in the Volume box and choose the correct unit (mL)
  • Click the “Calculate” button
  • The answer of 17.513 mg appears in the Mass box. In a similar way, you may calculate the volume and concentration.

Dilution Calculator allows you to calculate how to dilute a stock solution of known concentrations. For example, you may Enter C1, C2 & V2 to calculate V1, as detailed below:

What volume of a given 10 mM stock solution is required to make 25 ml of a 25 μM solution?
Using the equation C1V1 = C2V2, where C1=10 mM, C2=25 μM, V2=25 ml and V1 is the unknown:
  • Enter 10 into the Concentration (Start) box and choose the correct unit (mM)
  • Enter 25 into the Concentration (End) box and select the correct unit (mM)
  • Enter 25 into the Volume (End) box and choose the correct unit (mL)
  • Click the “Calculate” button
  • The answer of 62.5 μL (0.1 ml) appears in the Volume (Start) box
g/mol

Molecular Weight Calculator allows you to calculate the molar mass and elemental composition of a compound, as detailed below:

Note: Chemical formula is case sensitive: C12H18N3O4  c12h18n3o4
Instructions to calculate molar mass (molecular weight) of a chemical compound:
  • To calculate molar mass of a chemical compound, please enter the chemical/molecular formula and click the “Calculate’ button.
Definitions of molecular mass, molecular weight, molar mass and molar weight:
  • Molecular mass (or molecular weight) is the mass of one molecule of a substance and is expressed in the unified atomic mass units (u). (1 u is equal to 1/12 the mass of one atom of carbon-12)
  • Molar mass (molar weight) is the mass of one mole of a substance and is expressed in g/mol.
/

Reconstitution Calculator allows you to calculate the volume of solvent required to reconstitute your vial.

  • Enter the mass of the reagent and the desired reconstitution concentration as well as the correct units
  • Click the “Calculate” button
  • The answer appears in the Volume (to add to vial) box
In vivo Formulation Calculator (Clear solution)
Step 1: Enter information below (Recommended: An additional animal to make allowance for loss during the experiment)
Step 2: Enter in vivo formulation (This is only a calculator, not the exact formulation for a specific product. Please contact us first if there is no in vivo formulation in the solubility section.)
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Calculation results

Working concentration mg/mL;

Method for preparing DMSO stock solution mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.

Method for preparing in vivo formulation:Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O,mix and clarify.

(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
             (2) Be sure to add the solvent(s) in order.

Clinical Trial Information
Title:Assessing the Effect of Shatavari Supplementation on Bone and Skeletal Muscle Health in Healthy Postmenopausal Women
Status:Completed
updateDate:2021-08-30
Ctid:NCT05025917

Link: https://clinicaltrials.gov/ct2/show/NCT05025917

Conditions:Muscle Weakness|Osteoporosis, Postmenopausal
Interventions:Magnesium stearate
Phase:N/A
Title:A Study to Investigate the Effect of Inhaling Single Doses of Different Formulations of GW642444M in Asthmatic Patients
Status:Completed
updateDate:2017-08-10
Ctid:NCT00702910

Link: https://clinicaltrials.gov/ct2/show/NCT00702910

Conditions:Pulmonary Disease, Chronic Obstructive
Interventions:Magnesium Stearate
Phase:Phase 1
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