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Mallinckrodt
Mallinckrodt Pharmaceuticals (SpecGx LLC) is the world leader in the production of high-quality, reliably performing stearates for the pharmaceutical, nutraceutical, and food industries.
Mallinckrodt Pharmaceuticals, a multibillion-dollar specialty pharmaceutical company, is dedicated to its mission of listening for needs and delivering solutions. With a history spanning 150 years, Mallinckrodt has leveraged its unique strengths, experience, and expertise to significantly improve people's lives through innovation and patient-centered solutions.
The company's growing portfolio addresses a wide range of health conditions, focusing on autoimmune and rare diseases across various specialty areas such as neurology, rheumatology, nephrology, pulmonology, and ophthalmology.
Additionally, Mallinckrodt is committed to immunotherapy, neonatal respiratory critical care therapies, analgesics, and gastrointestinal products. At the core of Mallinckrodt's mission is a commitment to the patients it serves, aiming to deliver solutions that lead to healthier futures. The company's values of being patient-centric, integrity, innovation, and collaboration guide its efforts to be an innovation-driven specialty pharmaceutical leader.
The world leader in high performance stearates
Mallinckrodt Pharmaceuticals (SpecGx LLC) is the world leader in the production of high-quality, reliably performing stearates for the pharmaceutical, nutraceutical, and food industries. Their stearates have been manufactured at their cGMP plant in St. Louis, MO for over a century using a unique water-based precipitation process to yield a consistent, “platelet-like” particle that is considered a true monohydrate.
High purity pharmaceutical grade stearates are offered with the DMF to support your formulation work and food grade stearates are available with kosher, halal, and RSPO mass balance certifications.
Mallinckrodt goes above and beyond global compendia requirements to ensure consistent performance by controlling additional physical parameters such as surface area, particle size, and bulk density. The result is measurably better stearates that provide better powder flowability and blend uniformity while avoiding capping, lamination, pitting, and sticking in tablets.
Monographs
Industries
Food
Applications
- Dough enhancer
- Dry mixes
- Hard candy
- Gum
Pharmaceuticals
Applications
- Tablets
- Suppositories
- Injections
- Topicals
Nutraceuticals
Applications
- Tablets
- Topicals
Product Information
Product Highlight: Stear-O-Wet™
Stear-O-Wet™ is a spray-dried mixture of magnesium stearate and sodium lauryl sulfate. The addition of the sodium lauryl sulfate surfactant makes this product a hydrophilic magnesium stearate, reducing the uncertainty of attempting to dry blend the two in a consistent, homogeneous manner. Wettable formulations improve disintegration and dissolution of drug substances in tablets and are particularly useful in formulations with solubility issues. As such, Stear-O-Wet™ streamlines the supply chain in that manufacturers only need to source and stock one co-processed excipient instead of two separate ingredients. Stear-O-Wet™ is uniform, avoiding the potential issue of over-blending if added separately, which can slow the rate of active ingredient dissolution due to the hydrophobic nature of magnesium stearate.
Stearates Selection Table
Type | Product | Source | Specifications | Kosher for Passover | Halal | RSPO Mass Balance | Notes |
Aluminum Monostearate (CAS # 7047-84-9) | HyQual™ 2263 | Palm | NF | √ | √ | √ | Promotes gelling in oil-based preparations |
Calcium Stearate (CAS # 1592-23-0) | HyQual™ 2248 | Palm | NF, FCC | √ | √ | √ | Standard particle size; works well with ibuprofen |
HyQual™ 2249 | Palm | NF | √ | √ | √ | Fine powder, offering a smaller particle size option | |
Food Grade 5853 | Palm | FCC | √ | √ | √ | Food grade | |
Magnesium Stearate (CAS # 557-04-0) | NF Veg 1726 | Soy | NF, EP, BP, JP, FCC | N/A | Suitable for formulations with a larger particle size | ||
HyQual™ 2257* | Palm | NF, EP, BP, JP, ChP, FCC | √ | √ | √ | Most frequent choice for pharmaceutical applications | |
HyQual™ 5712* | Palm | NF, EP, BP, JP, ChP | √ | √ | √ | Second most frequent choice for pharmaceutical applications, with a slightly smaller particle size than HyQual™ 2257 | |
Stear-O-Wet™ 8577** | Palm | Magnesium Stearate: NF, EP, BP, JP, ChP, FCC Sodium Lauryl Sulfate: NF | √ | √ | 2-in-1 combination; spray-dried mixture of magnesium stearate and sodium lauryl sulfate | ||
Nutraceutical 4024 | Palm | NF | √ | √ | √ | Nutraceutical grade | |
Food Grade 3508 | Palm | FCC | √ | √ | √ | Food grade | |
Powder 434 5774 | Palm | √ | Industrial grade fine particles |
*Drug Master File (DMF) available for referencing
**DMF and Active Substance Master File (ADMF) available for referencing
Product Categories
Dimethylisopropanolamine
Dimethylisopropanolamine is a clear, colorless to yellow liquid at room temperature with amine-like odor and is miscible in water.
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Triphenyphosphine
Triphenyphosphine is a tertiary phosphine and serves as a reducing agent and neutral ligand, where it is widely used in the production of organic and organometallic compounds.
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3-Amino 1-Propanol
3-Amino 1-Propanol is a clear, colorless to yellow liquid at room temperature with an amine-like odor finding uses as a pH modifier, co-reactant, dispersing aide and emulsion film
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AMP ULTRA PC™
AMPD ULTRA PC helps to reduce emulsion particle size and enhance rheological properties. It aids in pigment dispersion and improves dispersion stability, making it particularly well-suited for use in mascara and color cosmetics.
View product lineAMP ULTRA PC™
AMPD ULTRA PC helps to reduce emulsion particle size and enhance rheological properties. It aids in pigment dispersion and improves dispersion stability, making it particularly well-suited for use in mascara and color cosmetics.
View product lineAMP ULTRA PC™
Advancion’s high-purity ULTRA PC™ multifunctional amino alcohols are specifically designed to deliver robust performance across a broad array of personal care and cosmetics applications, including hair care and styling, color cosmetics and skin care
View product lineAMP ULTRA PC™
Advancion’s high-purity ULTRA PC™ multifunctional amino alcohols are specifically designed to deliver robust performance across a broad array of personal care and cosmetics applications, including hair care and styling, color cosmetics and skin care
View product lineFeatured Products
3-Amino 1-Propanol
3-Amino 1-Propanol is a clear, colorless to yellow liquid at room temperature with an amine-like odor finding uses as a pH modifier, co-reactant, dispersing aide and emulsion film
View ProductDimethylisopropanolamine
Dimethylisopropanolamine is a clear, colorless to yellow liquid at room temperature with amine-like odor and is miscible in water.asfasfasfdfasdh
View ProductTriphenyphosphine
Triphenyphosphine is a tertiary phosphine and serves as a reducing agent and neutral ligand, where it is widely used in the production of organic and organometallic compounds.
View ProductDimethylisopropanolamine
Dimethylisopropanolamine is a clear, colorless to yellow liquid at room temperature with amine-like odor and is miscible in water.asfasfasfdfasdh
View ProductProducts Available
| Product Name | Supplier | Grade | Package Type | Weight | Billing Price | Price (Package) | |
|---|---|---|---|---|---|---|---|
| HyQual 5853 Calcium Stearate, Food Grade (Kosher), Powder, 25 lb Bag | SPECGXM | Food | Bag | 25.00 lbs | -- |
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| HyQual 5853 Calcium Stearate, Food Grade (Kosher), Powder, 75 lb Drum | SPECGXM | Food | Drum | 75.00 lbs | -- |
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| HyQual 2257 Magnesium Stearate, NF/ EP/ JP Grade, Powder, 88 lb Drum | SPECGXM | NF | Drum | 88.19 lbs | -- |
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| Magnesium Stearate 3508 | SPECGXM | Food | Drum | 88.18 lbs | -- |
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| HyQual 5712 Magnesium Stearate, NF Grade (Kosher), Powder, 88 lb Drum | SPECGXM | NF | Drum | 88.19 lbs | -- |
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| Magnesium Stearate NF Veg 1726 | SPECGXM | NF | Drum | 75.00 lbs | -- |
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