Sourcing high-purity, standardized D-Mannitol Powder with precise polymorph control, ultra-low moisture absorption, and superior tablet compactibility is crucial for pharmaceutical formulation and high-end food manufacturing.

SKU Code	Grade & Particle Size Description	Specification Limits	Primary Industrial Intent
MAN-PH-USP	Standard Crystalline Mannitol (USP/EP/BP)	Purity ≥ 98.0% - 102.0%	Ideal for wet granulation, freeze-drying (lyophilization) bulking agents, and stable capsule formulations.
MAN-DC-200G	Direct Compression Spray-Dried Mannitol	D50: 160μm - 220μm / High Flow	Specifically engineered for direct-tableting processes, chewable tablets, and rapid-melt oral formulations (ODTs).
MAN-FD-120M	Food & Beverage Grade Fine Powder	Passing 100-120 Mesh / Sweetness ~50%	Excellent clean-label sugar alternative, dust-coating for premium chewing gums, and sugar-free mints.

Analysis Parameter	Physicochemical Specification Limits	Global Regulatory Compliance Status
ACTIVE ASSAY & SOLUBILITY
D-Mannitol Content (HPLC)	98.0% - 102.0% (USP / EP / JP Compliant)	Strictly verified via high-performance liquid chromatography. Free of reducing sugars and other polyols.
Melting Range	164°C to 169°C	Ensures highly consistent thermal properties, guaranteeing raw materials do not exhibit unstable crystalline variations.
CONTAMINANT MANAGEMENT & BIOLOGICAL AUDITS
Heavy Metals & Nickel	Pb ≤ 0.5 ppm | Ni ≤ 1.0 ppm | As ≤ 1.0 ppm	Monitored closely by ICP-MS. Meets ICH Q3D elemental impurity requirements and EP standards.
Microbial & Bacterial Endotoxins	Endotoxins ≤ 4.0 IU/g (For Injectable Grade)	Manufactured in GMP-certified Class D clean rooms. Certified pyrogen-free and safe for parentals and IV fluids.

Application Track 1: Solid Dosage Tablet Formulations (Direct Compression Mannitol)

Designed specifically for modern high-speed rotary tablet presses. It provides superb powder flowability, eliminates die cavity filling errors, and prevents common defects like capping or sticking.

R&D Directives: Pair **MAN-DC-200G** with lubricants (such as Magnesium Stearate at ≤ 1.0%) to optimize ejection force while maintaining ideal tablet dissolution kinetics.

Application Track 2: Lyophilized Injectables & Inhalation Carriers

Exhibits strong crystalline structures that prevent collapse during vacuum drying. Acts as a highly pure, inert carrier for biological drugs, protecting fragile peptide structures.

R&D Directives: Suitable for multi-component formulations. Recommended for use as a stabilizer/excipient in sterile powder injections, meeting strict endotoxin-free standards.

Application Track 3: Premium Food & Sugar-Free Confectionery

Delivers a mild, pleasant sweetness (~50% of sucrose) with a negative heat of solution (-120 kJ/kg), offering an excellent natural cooling sensation. Ideal for sugar-free food coatings.

R&D Directives: Excellent anti-tack dusting agent for chewing gum strips and starch-molded soft candies, preventing sticky surfaces under high-humidity shelf storage.

Case Study 1: Solving Weight Variation in ODT Chewable Tablets (Osaka, Japan)

Operational Challenge: A global pharmaceutical manufacturer experienced high rejection rates due to poor powder flow and significant tablet weight variation on high-speed rotary presses during ODT (Orally Disintegrating Tablet) production.

The Technical Execution: The formulation team replaced local crystalline powder with our spray-dried **MAN-DC-200G Direct Compression Mannitol** (D50: 180μm).

✓ Commercial Outcome: Tablet weight variance decreased to less than 1.0%, machine running speeds increased by 40%, and the tablets achieved rapid disintegration (within 25 seconds) in the mouth.

Case Study 2: Preventing Stickiness and Capping in Low-Sugar Confectionery (Chicago, USA)

Operational Challenge: A confectionery brand struggled with severe chewing gum surface stickiness and rapid texture degradation when exported to tropical high-humidity environments.

The Technical Execution: They introduced our **MAN-FD-120M** ultra-fine, low-hygroscopicity D-Mannitol powder as a surface dusting and anti-tack agent.

✓ Commercial Outcome: Successfully extended product shelf life by 8 months under hot climate distribution, completely eliminating retail stickiness complaints and repacking costs.

• Standard Bulk Cargo & Multi-Layer Protective Packaging

Supplied in robust 25kg multi-wall Kraft paper bags or fiber drums with double-layer PE food-grade inner liners. Fully heat-sealed to eliminate micro-moisture ingress and transit damage.

• Warehouse Environment Thresholds

Store in dry, clean, well-ventilated areas away from direct sunlight, strong odors, and extreme temperatures. Highly recommended to keep temperatures below 25°C and relative humidity below 60%.

• Global Shipping Manifests & Auditing Credentials

Every commercial batch is accompanied by an extensive quality dossier: Batch COA, HPLC crystalline polymorph assay sheets, heavy metals screening reports, non-GMO certificates, and Kosher/Halal compliance records.

Q1: How do you guarantee stable polymorph control in your pharmaceutical Mannitol?

A: We utilize advanced crystalline monitoring and low-temperature controlled crystallization processes. Every pharmaceutical-grade batch is analyzed via X-ray Powder Diffraction (XRPD) and DSC to verify over 99% pure Beta-polymorph, preventing crystalline transition under long-term shelf storage.

Q2: What makes your DC Grade Mannitol different from standard crystalline powder?

A: Standard crystalline Mannitol has poor flow properties and low compressibility, requiring wet granulation. Our DC Grade Mannitol is produced via continuous spray-drying, generating spherical, porous granules with large surface areas. This enables direct tableting with superb flowability and high compactibility.

Q3: Is your D-Mannitol safe for diabetics, and does it support tooth health?

A: Yes. D-Mannitol is a low-glycemic polyol that has a very low impact on blood glucose and insulin levels, making it fully suitable for diabetic-friendly formulations. Additionally, it is non-cariogenic (does not promote tooth decay), which is ideal for sugar-free chewing gums and ODT oral health products.

Q4: How do you manage nickel residues and heavy metals in your raw materials?

A: Since D-Mannitol is manufactured through the catalytic hydrogenation of fructose, nickel contamination is a common risk. Our manufacturing plant utilizes advanced multi-stage ion-exchange filtration to reduce nickel residues to far below the European and US Pharmacopoeia limit (≤ 1.0 ppm), verified via ICP-MS.

Q5: What is the MOQ and standard delivery time, and can we request sample validation?

A: Our wholesale MOQ is 1,000kg (1 pallet) for industrial orders, but we accommodate smaller trial batches for verified pharmaceutical and beverage brands. We provide 100g–500g free samples alongside full lab COA and PSD chromatography files for your technical evaluation.